GLP-1 / Weight Loss

Harbin Jixianglong Biotech Co., Ltd.

FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd., a Chinese manufacturer of peptide APIs including semaglutide and tirzepatide, following a November 2025 inspection. The agency found the firm purchased semaglutide API from unapproved suppliers, repackaged and relabeled it under its own name with falsified manufacturing and retest dates, and distributed it to the U.S. market — conduct FDA characterized as potentially circumventing Import Alert 66-80 safeguards. Additional violations included lack of process and cleaning validation, inadequate analytical method validation, insufficient water quality controls, and drug listing/misbranding violations. The firm was placed on Import Alert 66-40 (detention without physical examination), removed from the GLP-1 Green List, and initiated a voluntary recall of two semaglutide API batches.

Apr 2026CRITICAL

New Life Pharma LLC

FDA issued a warning letter to New Life Pharma LLC (Northvale, NJ) after a February 2026 inspection found the company was manufacturing and distributing unapproved semaglutide and tirzepatide sterile multi-dose vials — GLP-1 drugs shipped primarily to weight loss clinics and med spas — without FDA approval, proper registration, or adequate sterility controls. The products were deemed unapproved new drugs, misbranded, and adulterated due to pervasive CGMP failures including no aseptic process validation, no environmental monitoring, and no sterility testing. The company also denied FDA investigators access to portions of its manufacturing suite, further adulterating the drugs under FD&C Act section 501(j). A voluntary recall of all distributed batches was issued on February 25, 2026, and FDA demanded the firm confirm it will permanently cease drug manufacturing.

Apr 2026CRITICAL

ProRx LLC

ProRx LLC, a 503B outsourcing facility in Exton, PA, received an FDA Warning Letter following a September 2025 inspection that found the company compounding tirzepatide and semaglutide injectable products under insanitary conditions with serious sterility assurance failures. The facility violated section 503B by using tirzepatide bulk drug substance not on the 503B bulks list, omitting required label statements, and failing to maintain adequate adverse event reporting procedures. Multiple CGMP violations were cited including inadequate contamination investigations, blocked first air during aseptic operations, and use of non-sterilized equipment in ISO 5 areas. FDA demanded a written response within 15 working days and warned that failure to correct violations may result in seizure or injunction.

FormPour

FDA issued a warning letter to FormPour (Shuja Arshad, Canton, MI) regarding the sale of 'SMGT-GLT-1 Nano Microneedle Patch' on eBay, which FDA determined is an unapproved new drug under section 505(a) of the FD&C Act. The product's labeling made explicit disease-treatment claims for Type 2 Diabetes, weight loss, and cardiovascular protection, establishing its intended use as a drug. Because no approved NDA is in effect for this product, its interstate sale violates sections 301(d) and 505(a) of the FD&C Act. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure or injunction.

Prime Sciences

FDA issued a warning letter to Prime Sciences (Scottsdale, AZ) on March 31, 2026, after reviewing their website and finding that they were selling unapproved new drugs — including Cagrilintide, Retatrutide, Semaglutide, Tirzepatide, Mazdutide, and BAC water — in violation of sections 301(d) and 505(a) of the FD&C Act. Despite labeling the products as 'for laboratory research purposes only,' the website's marketing copy made clear the products were intended for human use in weight loss and diabetes management. FDA warned that failure to correct these violations could result in seizure and injunction, and required a written response within fifteen working days.

Guangzhou Huli Technology Co., Ltd. dba Fantasy Face

FDA issued a warning letter to Guangzhou Huli Technology Co., Ltd. dba Fantasy Face (operating an eBay store) for selling 'Googeer GLP-1 Weight Control Oral Solution' in the United States without an approved new drug application. The product's labeling made drug-intended-use claims including weight management, blood sugar balance, and body shaping, qualifying it as an unapproved new drug under FD&C Act sections 301(d) and 505(a). FDA requires written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

PekCura Labs

FDA issued a warning letter to PekCura Labs (Jonathan Snider and Jonathan Speck, Pensacola, FL) on March 31, 2026, after reviewing their website in January 2026. The agency found that PekCura Labs was selling injectable peptide products marketed as 'GLP-1-S,' 'GLP-2-T,' 'GLP-3-R,' and 'Bacteriostatic Water' — all unapproved new drugs under section 505(a) of the FD&C Act — with product pages making explicit disease-treatment and body-weight-reduction claims referencing clinical studies. Despite 'research use only' disclaimers, FDA determined the products were intended for human use based on the marketing language, and warned that failure to correct violations could result in seizure and injunction.

Mile High Compounds LLC

FDA issued a warning letter to Mile High Compounds LLC (Clifton, CO) on March 31, 2026, after reviewing the company's website and affiliated community forum from January to March 2026. The company was found to be selling unapproved new drugs — including products containing semaglutide ('GLP-1 SM'), tirzepatide ('GLP-2 TRZ'), retatrutide ('GLP-3 RT'), and bacteriostatic water ('BAC Water') — marketed under research-only labels but with clear human-use dosing and therapeutic claims. FDA determined these products are intended for human use to treat obesity and metabolic conditions, making them unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act. The company was directed to respond within 15 working days, with failure to comply potentially resulting in seizure and injunction.

Gram Peptides

FDA issued a warning letter to Gram Peptides (Bernard Gramlich, Rancho Santa Fe, CA) on March 31, 2026, after reviewing the company's website and finding it offered Retatrutide, Tirzepatide, and Bacteriostatic Water for Injection for sale as unapproved new drugs. Despite 'Research Use Only' disclaimers, the website's marketing claims—describing appetite suppression, weight loss, glucose regulation, and metabolic benefits—established intended human drug use under the FD&C Act. FDA cited violations of sections 301(d) and 505(a) of the FD&C Act and warned that failure to correct may result in seizure or injunction.

Lovega LLC dba Pink Pony Peptides

FDA issued a warning letter to Lovega LLC dba Pink Pony Peptides (Susan Vega, Wellington, FL) after reviewing the company's website in December 2025 and finding that three products — 'GLP-2 TZ' (tirzepatide), 'GLP-3 RT' (retatrutide), and 'Bacteriostatic Water' — were being sold as unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act. Despite 'research purposes only' disclaimers, the website's marketing copy made explicit human-use drug claims including appetite suppression, fat loss, insulin sensitivity, and glucose control. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Novo Nordisk Inc.

FDA issued a Warning Letter to Novo Nordisk Inc. (NNI) following a January–February 2025 inspection that revealed serious violations of postmarketing adverse drug experience (PADE) reporting regulations under 21 CFR 314.80, affecting products including semaglutide and liraglutide. NNI failed to develop adequate written procedures ensuring timely 15-day Alert reporting of serious and unexpected ADEs, improperly rejected reportable cases based on reporter-assessed causality, and failed to promptly investigate ADEs subject to expedited reporting. FDA found systemic failures in NNI's pharmacovigilance program—including inadequate vendor oversight and corrective actions—and requires a written response within 15 business days detailing remediation steps, with the warning that failure to adequately address these issues may lead to further regulatory action.

Belle Health LLC dba Belle

FDA issued a warning letter to Belle Health LLC dba Belle (Draper, UT) on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labeling that falsely identified 'Belle' as the compounder when it is not. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Dripgym Mobile Parent, LLC dba Amp Health

FDA issued a warning letter to Dripgym Mobile Parent, LLC dba Amp Health (Los Angeles, CA) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The website falsely identified 'Amp Health' as the compounder on product labels, and made claims implying FDA approval by referencing the same active ingredients as FDA-approved brand-name drugs (Wegovy, Ozempic, Saxenda, Mounjaro, Zepbound). These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Feb 2026WARNING

24HrDoc, Inc. dba 24HrDoc

FDA issued a warning letter to 24HrDoc, Inc. (Houston, TX) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The website falsely implied 24HrDoc was the compounder of the drugs by displaying its name on product labels, and made claims that the compounded products contained the 'same ingredients' as FDA-approved brand-name drugs (Ozempic, Wegovy, Mounjaro, Zepbound), which FDA found misleadingly implied FDA approval or evaluation for safety and effectiveness. The products were deemed misbranded under FDCA sections 502(a) and 502(bb), with their interstate commerce introduction constituting a prohibited act under section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to comply may result in seizure or injunction.

Newman Clinic, PLLC dba Newman Clinic

FDA issued a warning letter to Newman Clinic, PLLC (operated by Donna Newman, DMSc, PA-C) on February 20, 2026, after reviewing the clinic's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The clinic's website falsely implied Newman Clinic was the compounder of these drugs by displaying its name on product labels, and made claims suggesting the compounded products were FDA-approved by stating they contained the 'Same Ingredient as Ozempic® and Wegovy®' and 'Same Ingredient as Mounjaro® and Zepbound®.' FDA found these representations misbranded the products under FDCA sections 502(a) and 502(bb), and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

MEDVi, LLC dba MEDVi

FDA issued a warning letter to MEDVi, LLC dba MEDVi on February 20, 2026, after reviewing its website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The agency found that MEDVi's website falsely implied the company was the compounder of these drugs (when it was not) and that claims comparing its products to FDA-approved brand-name drugs (Wegovy, Ozempic, Mounjaro, Zepbound) misleadingly implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to act could result in seizure or injunction.

Kin Meds

FDA issued a warning letter to Kin Meds (Manhattan Beach, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The website falsely identified 'Kin Meds' as the compounder on product labels when it is not, and made claims implying FDA approval or evaluation of compounded products that have not been approved. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Peaks Curative, LLC dba Peaks

FDA issued a warning letter to Peaks Curative, LLC dba Peaks on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide products. The website falsely implied FDA approval of compounded drug products and misidentified 'Peak Now' as the compounder on product labels. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Strut Health, LLC dba Strut

FDA issued a warning letter to Strut Health, LLC dba Strut (CEO Simal Patel, MD) on February 20, 2026, concerning false or misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that Strut's website falsely implied the company itself was the compounder of these drugs (by displaying 'Strut' on product labels) and that claims such as 'Generic Zepbound, Mounjaro' falsely implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Premium Health Management Inc. dba Premium Health

FDA issued a warning letter to Premium Health Management Inc. dba Premium Health (Santa Ana, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The FDA found that the website falsely implied Premium Health was the compounder of the products and that the products had received FDA approval or evaluation for safety and effectiveness. The products were deemed misbranded under FDCA sections 502(a) and 502(bb), with their interstate commerce constituting a prohibited act under section 301(a). The company was given 15 working days to respond with corrective steps, and was warned that failure to comply may result in seizure or injunction.

Weightless Medical LLC dba WeightCare

FDA issued a warning letter to Weightless Medical LLC dba WeightCare on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labels identifying 'WeightCare' as the compounder when it is not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these misbranded products into interstate commerce violates section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Aspen Aesthetics dba Fifty 410

FDA issued a warning letter to Aspen Aesthetics dba Fifty 410 (Prosper, TX) on February 20, 2026, concerning its website marketing of compounded semaglutide and tirzepatide products. The agency found two categories of misbranding violations: (1) the product labels displayed on the website identified 'Fifty 410' as the compounder when it is not, constituting a false or misleading representation under FDCA §§ 502(a) and 502(bb); and (2) the claim 'clinically proven ingredients' falsely implied FDA approval or evaluation for safety and effectiveness for unapproved compounded drugs. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Join Josie

FDA issued a warning letter to Join Josie, a website offering compounded semaglutide and tirzepatide products, for misbranding violations under FDCA sections 502(a) and 502(bb). The site falsely displayed the 'Join Josie' label on compounded drug products, implying the company was the compounder when it was not, and made misleading claims linking its compounded products to FDA-approved brands Wegovy® and Zepbound®, implying FDA approval or evaluation that does not exist. FDA found these representations false or misleading, constituting misbranding and prohibited interstate commerce under section 301(a). Join Josie was directed to respond within 15 working days with corrective steps, and warned that failure to comply may result in seizure or injunction.

Kare Solutions, LLC dba Zappy

FDA issued a warning letter to Kare Solutions, LLC dba Zappy (La Jolla, CA), a telehealth platform offering compounded semaglutide, tirzepatide, and liraglutide products, for misbranding violations under FDCA sections 502(a) and 502(bb). The website falsely displayed 'Zappy' on product labels implying it was the compounder, and made claims linking its compounded products to FDA-approved branded drugs (Wegovy®, Saxenda®, Zepbound®) and describing them as 'a proven medication' and 'clinically studied,' implying FDA approval that compounded drugs do not have. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Better Health Labs, Inc. dba Measured

FDA issued a warning letter to Better Health Labs, Inc. dba Measured (New York, NY) on February 20, 2026, after reviewing the company's website trymeasured.com in December 2025. The agency found that Measured's website falsely implied the company itself was the compounder of semaglutide and tirzepatide products by displaying the 'Measured' brand name on product labels, and that marketing claims comparing compounded products to FDA-approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro) falsely implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), and FDA warned that failure to adequately address violations may result in seizure and injunction.

MaxLife Technologies Inc. dba Maxlife

FDA issued a warning letter to MaxLife Technologies Inc. dba Maxlife (Irvine, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The company falsely labeled products with the 'Maxlife' brand as if it were the compounder, and made multiple claims that the compounded drugs were 'FDA-approved' or equivalent to FDA-approved branded products, when compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Levity Inc. dba Levity

FDA issued a warning letter to Levity Inc. dba Levity (Delray Beach, FL) on February 20, 2026, after reviewing their website in December 2025 and finding that compounded semaglutide and liraglutide products were marketed with false or misleading claims. The company's website displayed the 'Levity' brand name on product labels despite Levity not being the actual compounder, and used claims implying FDA approval by referencing brand-name drugs Ozempic, Wegovy, and Saxenda. FDA found these practices constitute misbranding under FDCA sections 502(a) and 502(bb), with interstate commerce violations under section 301(a), and warned that failure to respond could result in seizure or injunction.

PharmaZee

FDA issued a warning letter to PharmaZee (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified PharmaZee as the compounder of the drugs and made claims implying FDA approval or clinical validation for unapproved compounded products. FDA cited misbranding violations under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Genesis Health International Inc. dba Genesis

FDA issued a warning letter to Genesis Health International Inc. dba Genesis (Boynton Beach, FL) on February 20, 2026, after reviewing their website trygenesis.com in December 2025. The agency found that Genesis falsely represented itself as the compounder of semaglutide and tirzepatide products by displaying the 'Genesis' name on product labels, and made misleading claims implying FDA approval by stating their products contain 'the same active ingredient as Ozempic® and Wegovy®' and 'Same active ingredient as Mounjaro®.' These practices rendered the products misbranded under FDCA sections 502(a) and 502(bb), and FDA warned that failure to address violations may result in seizure and injunction.

FitRX, LLC dba FitRx

FDA issued a warning letter to FitRX, LLC dba FitRx (New York, NY) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the FitRx label appearing on product images implies FitRx is the compounder when it is not, and (2) website claims linking their compounded products to FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro) falsely imply FDA approval or evaluation for safety and effectiveness. Both violations constitute misbranding under FDCA sections 502(a) and 502(bb), and FitRx was given 15 working days to respond with corrective steps or face potential seizure and injunction.

Good Girl LLC dba GoodGirlRX

FDA issued a warning letter to Good Girl LLC dba GoodGirlRX (CEO Savannah Chrisley) in February 2026 after reviewing the company's website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely labeled products as if GoodGirlRX were the compounder, and made claims that compounded drugs were 'FDA-approved' or 'clinically proven,' when compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and warned that failure to address violations may result in seizure or injunction.

Feb 2026WARNING

Lean Rx, Inc. dba SkinnyRx

FDA issued a warning letter to Lean Rx, Inc. dba SkinnyRx (Sacramento, CA) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the website's product images display the 'SkinnyRx' label, falsely implying SkinnyRx is the compounder of the drugs, and (2) marketing claims imply FDA approval or equivalence to FDA-approved medications, which is false for compounded products. FDA found these practices constitute misbranding under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Zeuss LLC dba Zeuss

FDA issued a warning letter to Zeuss LLC dba Zeuss on February 20, 2026, regarding its website marketing of compounded tirzepatide products. The agency found the products misbranded under FDCA sections 502(a) and 502(bb) because the website falsely implied Zeuss was the compounder of the drugs, and made claims suggesting the compounded products were FDA-approved or clinically proven when they are not. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics

FDA issued a warning letter to Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The company's website falsely implied it was the compounder of these drugs by displaying its name on product labels, and made claims linking its compounded products to FDA-approved brand-name drugs (Ozempic®, Mounjaro®, Wegovy®, Rybelsus®, Zepbound®), thereby misleadingly implying FDA approval or evaluation for safety and effectiveness. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

BluefitMD

FDA issued a warning letter to BluefitMD (Lakewood Ranch, FL) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified BluefitMD as the compounder of these drugs when it was not, and marketing language implied the compounded products shared FDA-approved status with brand-name drugs like Ozempic®, Wegovy®, Mounjaro®, and Zepbound®. FDA determined the products were misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited interstate commerce under section 301(a). BluefitMD was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Feb 2026WARNING

Bliv Wellness LLC dba Bliv

FDA issued a warning letter to Bliv Wellness LLC dba Bliv (Ogden, UT) on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with the 'Bliv' name on the pictured product labels, falsely implying Bliv is the compounder of those drugs when it is not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these misbranded products into interstate commerce violates section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to adequately address violations may result in seizure or injunction.

Thrive Health and Wellness, LLC dba Thrive Health Solutions

Thrive Health and Wellness, LLC dba Thrive Health Solutions (Englewood, CO), owned by Doug Hatch, received an FDA Warning Letter following a March–April 2025 inspection that found serious sterility deficiencies in the repackaging of drug products including NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections. The firm conducted aseptic operations outside certified ISO 5 areas, used non-sterile gloves and wipes, had carpeted flooring in processing areas, and never performed media fills, rendering products adulterated under FDCA section 501(a)(2)(A). The products were also cited as unapproved new drugs and misbranded under FDCA sections 505(a) and 502(f)(1); the firm voluntarily ceased repackaging and initiated a recall of all affected products dispensed between January 2 and April 18, 2025. FDA warned that failure to adequately address violations may result in seizure and injunction.

Jan 2026CRITICAL

FTC Consent Order

NextMed

NextMed (Southern Health Solutions, Inc.), a telemedicine company offering weight-loss membership programs, was charged by the FTC with using deceptive claims about costs and weight-loss outcomes, fake reviews, and fake testimonials to attract consumers. The company also concealed material terms and conditions of its membership programs. Under the proposed consent order, NextMed and its principals agreed to pay $150,000, which is expected to be used to provide refunds to affected consumers.

Dec 2025CRITICAL

Apothecary Pharma, LLC

FDA issued a warning letter to Apothecary Pharma, LLC (Cary, NC), a 503B outsourcing facility, following a May 2025 inspection that revealed serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility compounded GLP-1 products including Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL with inadequate labeling, deficient adverse event reporting procedures, and multiple insanitary aseptic processing practices that rendered drug products adulterated and misbranded. Because the 503B conditions were not met, the compounded drugs are also unapproved new drugs subject to FDA approval requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Sep 2025WARNING

Ralph A. DeFronzo, M.D.

FDA issued a warning letter to Dr. Ralph A. DeFronzo, a clinical investigator at the University of Texas Health Science Center in San Antonio, following a December 2024 inspection of two clinical investigations involving investigational drugs, one of which involved GLP-1 receptor agonist-related eligibility criteria. The letter cites two primary violations: (1) failure to ensure subjects met protocol eligibility criteria before enrollment — all seven enrolled subjects had disqualifying blood pressure readings, eGFR values, or were on excluded medications (SGLT2 inhibitors and GLP-1 receptor agonists) — and (2) failure to promptly report a material change in study design (from a double-blind placebo-controlled trial to a pilot feasibility study) to the IRB before enrolling and treating all seven subjects. FDA found Dr. DeFronzo's corrective responses inadequate and required a written response within 15 business days detailing actions taken to prevent future violations, warning that failure to adequately respond may lead to regulatory action.

Chengdu Brilliant Biopharmaceutical Co., Ltd.

FDA issued a warning letter to Chengdu Brilliant Biopharmaceutical Co., Ltd., a Chinese API manufacturer, for significant CGMP deviations related to its Semaglutide (GLP-1 receptor agonist) API. The agency found the firm failed to conduct process validation for Semaglutide and failed to perform identity testing on incoming raw materials used in API manufacturing. FDA placed all drugs from this facility on Import Alert 66-40 as of July 9, 2025, and warned that continued non-compliance could result in refused admission of articles into the United States under the FD&C Act.

motionpharmacy.com

FDA issued a warning letter to motionpharmacy.com on September 10, 2025, for selling unapproved and misbranded prescription drugs to U.S. consumers over the internet without requiring a prescription. The site was found to be offering unapproved opioids (hydrocodone, oxycodone, hydromorphone, oxymorphone, promethazine/codeine), benzodiazepines (clonazepam, diazepam, lorazepam, alprazolam, bromazepam, bromazolam), Schedule II stimulants (lisdexamfetamine, methylphenidate, amphetamine, dextroamphetamine), and semaglutide (marketed as Ozempic) without valid FDA-approved drug applications. FDA demanded cessation of all such sales and a written corrective action response within 15 working days, warning that failure to comply may result in seizure or injunction.

Eli Lilly and Company

FDA issued a warning letter to Eli Lilly and Company (CEO David A. Ricks) regarding a direct-to-consumer online video promoting ZEPBOUND® (tirzepatide) that was posted on dayton247now.com on July 9, 2025. The video featured Eli Lilly representatives making claims about Zepbound's safety and effectiveness while entirely omitting all risk information — including the boxed warning for thyroid C-cell tumors — and failing to disclose the drug's limitations of use. FDA determined the video misbrands Zepbound in violation of the FD&C Act and also cited Eli Lilly for failing to submit the promotional material under Form FDA-2253 at the time of initial dissemination; Lilly was directed to respond within 15 working days, cease misleading communications, and disseminate corrective communications to the same audience.

Eli Lilly and Company

FDA issued a warning letter to Eli Lilly and Company (CEO David A. Ricks) on September 9, 2025, regarding a sponsored direct-to-consumer online video promoting ZEPBOUND® (tirzepatide) that aired on okcfox.com. The video featured Eli Lilly representatives making claims about Zepbound's safety and effectiveness while entirely omitting required risk information — including the boxed warning for thyroid C-cell tumors — and failing to disclose the drug's limitations of use. The video was also never submitted to FDA under Form FDA-2253 at the time of initial publication as required by regulation. FDA determined the video misbrands Zepbound in violation of the FD&C Act and demanded a written response within 15 working days, a corrective communication plan, and cessation of the misleading promotional materials, warning that failure to comply may result in seizure or injunction.

Eli Lilly and Company

FDA issued a warning letter to Eli Lilly and Company regarding a direct-to-consumer promotional video ('An Oprah Special: Shame, Blame, and the Weight Loss Revolution') that featured paid Eli Lilly consultants making false or misleading claims about the safety profile of Zepbound (tirzepatide) and Mounjaro (tirzepatide). The video omitted critical risk information—including contraindications related to MEN 2, acute kidney injury, suicidal behavior, and severe gastrointestinal disease—while paid consultants actively minimized boxed warning risks as 'overhyped' and described side effects as 'mild to moderate,' contrary to clinical trial data. FDA determined the video misbrands both drugs under the FD&C Act and that Eli Lilly failed to submit the promotional material under Form FDA-2253 at the time of initial dissemination, demanding a written response within 15 working days and a corrective communications plan, with threats of seizure and injunction for non-compliance.

Novo Nordisk Inc.

FDA issued a warning letter to Novo Nordisk Inc. regarding a 42-minute direct-to-consumer promotional video ('An Oprah Special: Shame, Blame, and the Weight Loss Revolution') that featured paid Novo Nordisk consultants making false or misleading claims about the safety profile of Wegovy, Ozempic, and Victoza. The video omitted critical boxed-warning risk information (including MEN 2 contraindication), downplayed serious adverse events such as pancreatitis and thyroid cancer as 'overhyped,' and characterized side effects as 'mild to moderate' contrary to clinical trial data. FDA determined the video misbrands all three drugs under the FD&C Act and demanded immediate cessation of the misleading communications, a written response within 15 working days, and a corrective advertising campaign directed at the same audience.

Healthon Inc. dba Healthon

FDA issued a warning letter to Healthon Inc. dba Healthon (Irvine, CA), a telehealth company, after reviewing its website in August 2025 and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims falsely implied that compounded products are equivalent to FDA-approved drugs such as Wegovy, Ozempic, Mounjaro, and Zepbound, and misrepresented the FDA-approval status of the active ingredients. FDA found the products misbranded and introduced into interstate commerce in violation of section 301(a), and warned that failure to correct violations may result in seizure or injunction.

Curex

FDA issued a warning letter to Curex, a Miami-based telehealth company, in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims implied that Curex's compounded products were equivalent to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound, when compounded drugs are not FDA-approved. FDA cited these claims as misbranding violations and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Elite Health Center

FDA issued a warning letter to Elite Health Center (Washington Township, NJ) on September 9, 2025, after reviewing the website eliterapidfatloss.com and finding a false or misleading claim about compounded semaglutide implying FDA approval of the compounded product. The claim falsely stated that compounded semaglutide received FDA approval as a diabetes treatment in 2017 and an obesity treatment in 2021, when in fact compounded drugs are never FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and directed Elite Health Center to cease the misleading language and respond within 15 working days, warning that failure to comply could result in seizure or injunction.

Matthew Stern, CEO MyStart Health LLC.

FDA issued a warning letter to Matthew Stern, CEO of MyStart Health LLC, in September 2025 after reviewing the company's website and finding that it marketed compounded semaglutide using claims that falsely implied equivalence to FDA-approved products such as Ozempic. The specific claims 'Generic Ozempic' and 'Save with generics that offer the same active ingredients and results' were found to be false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Fancy Meds, LLC dba Fancy Meds

FDA issued a warning letter to Fancy Meds, LLC dba Fancy Meds (Sunnyvale, CA) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved branded drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded cessation of the offending language and a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Remedy Meds

FDA issued a warning letter to Remedy Meds (Summit, NJ) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved brand-name drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Dr. Gater’s Weight Loss & Wellness

FDA issued a warning letter to Dr. Jameelah Gater, MD, of Dr. Gater's Weight Loss & Wellness (Eatonton, GA) in September 2025 after reviewing her website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely described compounded drugs as 'FDA Approved,' as 'generic' equivalents of brand-name GLP-1 drugs (Ozempic, Wegovy, Mounjaro), and as 'pharmacologically similar' to FDA-approved products, when compounded drugs are not FDA-approved. FDA cited misbranding violations under FDCA sections 502(a) and 502(bb) and warned that failure to correct violations may result in seizure or injunction.

Invigorate Med Spa

FDA issued a warning letter to Invigorate Med Spa (Pittsburgh, PA) in September 2025 after reviewing their website and finding that compounded semaglutide and tirzepatide products were marketed using the brand names of FDA-approved drugs (Wegovy and Mounjaro), falsely implying equivalence with those approved products. These claims were found to misbrand the compounded products under FDCA sections 502(a) and 502(bb), constituting prohibited introduction of misbranded drugs into interstate commerce under section 301(a). The FDA demanded immediate cessation of the misleading language and required a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Intimate Rose

FDA issued a warning letter to Intimate Rose (Kansas City, MO) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded cessation of the offending language and a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Healthy Male

FDA issued a warning letter to Healthy Male (Tempe, AZ) in September 2025 after reviewing their website and finding that marketing claims for compounded tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims implied the compounded products were equivalent to FDA-approved drugs, which they are not, constituting misbranding. FDA directed Healthy Male to immediately cease using the offending language and to provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

All American Wellness

FDA issued a warning letter to All American Wellness on September 9, 2025, after reviewing their website in August 2025 and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved drugs Ozempic and Mounjaro. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Body Good Studio

FDA issued a warning letter to Body Good Studio (Miami, FL) in September 2025 after reviewing their website and finding a false or misleading claim about compounded semaglutide products implying equivalence to FDA-approved drugs Ozempic and Wegovy. The claim violates FDCA sections 502(a) and 502(bb), rendering the products misbranded, and their interstate commerce distribution violates section 301(a). FDA demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

GLP-1 Solution

FDA issued a warning letter to GLP-1 Solution, a Germany-based online retailer, for selling unapproved and misbranded compounded drug products — including retatrutide, semaglutide, and tirzepatide — to U.S. consumers via its website glp1solution.store. Retatrutide products were cited as unapproved new drugs because retatrutide is not on the 503A or 503B bulks lists and is not an FDA-approved drug component. Claims on the site implied compounded semaglutide and tirzepatide were equivalent to FDA-approved branded products (Ozempic, Wegovy, Mounjaro), rendering those products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure, injunction, or import detention.

Lumimeds

FDA issued a warning letter to Lumimeds (Las Vegas, NV) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence with FDA-approved brand-name GLP-1 medications. Specifically, Lumimeds claimed these compounded products contain 'the same active ingredient as the brand name medications' and that 'GLP-1 was FDA-approved in 2017,' misleading consumers into believing the compounded products share FDA-approved status. FDA determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb), and directed Lumimeds to immediately cease the offending language and respond within 15 working days, warning that failure to comply could result in seizure or injunction.

Mane & Steel, LLC. dba Mane & Steel

FDA issued a warning letter to Mane & Steel, LLC (Sacramento, CA) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the company's claims implied their compounded products were equivalent to FDA-approved drugs, which they are not. FDA found the products misbranded and their interstate commerce introduction a prohibited act under section 301(a). The company was directed to cease the offending language immediately and provide a written corrective response within 15 working days, with failure to comply risking seizure and injunction.

Hims & Hers Health, Inc. dba Hims

FDA issued a warning letter to Hims & Hers Health, Inc. dba Hims (CEO Andrew Dudum) on September 9, 2025, after reviewing the hims.com website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the claims 'Same active ingredient as Ozempic and Wegovy' and 'Clinically proven ingredients' were found to falsely imply equivalence to FDA-approved products, which compounded drugs are not. FDA determined the products are misbranded and introduced into interstate commerce in violation of section 301(a), and warned that failure to correct violations may result in seizure or injunction.

directmeds.com, Inc. dba DirectMeds

FDA issued a warning letter to directmeds.com, Inc. dba DirectMeds (Bluffdale, UT) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied these products are equivalent to FDA-approved brand-name drugs. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

SemaBio

FDA issued a warning letter to SemaBio on September 9, 2025, after reviewing the company's website (sema.bio) and finding that it marketed compounded semaglutide products using the term 'generic semaglutide,' a claim FDA determined to be false or misleading because compounded drugs are not FDA-approved and the label implies equivalence to an approved product. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the interstate sale of such misbranded products violates section 301(a). FDA demanded immediate corrective action, including cessation of the misleading language, and warned that failure to comply may result in seizure or injunction.

Nuvo Life Health Inc. dba Nuvo Life Health

FDA issued a warning letter to Nuvo Life Health Inc. (Santa Monica, CA) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved drugs (Ozempic, Wegovy, and Mounjaro). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

EvoLife Wellness

FDA issued a warning letter to EvoLife Wellness (Boca Raton, FL) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied FDA approval. The claims 'FDA-Approved' and 'Clinically Proven: Semaglutide is FDA-approved for chronic weight management…' were deemed false or misleading under FDCA sections 502(a) and 502(bb) because compounded drug products are not FDA-approved. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Cosmo Medical Spa dba Cosmo Med Spa

FDA issued a warning letter to Cosmo Medical Spa dba Cosmo Med Spa, a Canadian-based telehealth/med spa operator, for selling compounded semaglutide products to U.S. consumers via its website while labeling them as 'Ozempic (semaglutide)' — falsely implying equivalence to an FDA-approved drug. The claims were found to constitute misbranding under FDCA sections 502(a) and 502(bb), and the interstate sale of these products violates section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure, injunction, or product detention at the U.S. border.

Elevate Your Wellness LLC, dba Elevated

FDA issued a warning letter to Elevate Your Wellness LLC (dba Elevated) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Bioverse, Inc. dba Bioverse

FDA issued a warning letter to Bioverse, Inc. dba Bioverse (New York, NY) in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence with FDA-approved brand-name drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded Bioverse cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

inspire.clinic

FDA issued a warning letter to inspire.clinic (Grand Prairie, TX) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs Ozempic and Mounjaro. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the clinic cease using the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

FitRX, LLC dba Zealthy

FDA issued a warning letter to FitRX, LLC dba Zealthy on September 9, 2025, citing that the company's website (getzealthy.com) made false or misleading claims implying its compounded semaglutide products are equivalent to FDA-approved brand-name drugs Wegovy and Ozempic. The claims violate FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded Zealthy cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Tuyo Health, Inc. dba Tuyo Health

FDA issued a warning letter to Tuyo Health, Inc. (Miami, FL) in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence with FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro). Because compounded drugs are not FDA-approved, these claims rendered the products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Lyfe Rx

FDA issued a warning letter to Lyfe Rx (Bee Cave, TX) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the claims implied the compounded products were equivalent to FDA-approved drugs, which they are not. FDA found the products to be misbranded and introduced into interstate commerce in violation of section 301(a). Lyfe Rx was directed to cease the offending language immediately and provide a written corrective response within 15 working days, with failure to comply potentially resulting in seizure or injunction.

Try Nova

FDA issued a warning letter to Try Nova (trynovamd.com) in September 2025 after reviewing the company's website and finding that its marketing of compounded semaglutide products contained a false or misleading claim implying equivalence to FDA-approved drugs Wegovy and Ozempic. The claim 'Same active ingredient as Wegovy & Ozempic' was found to misbrand the compounded products under FDCA sections 502(a) and 502(bb), because compounded drugs are not FDA-approved and cannot be represented as equivalent to approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Sep 2025WARNING

Lean Dreams LLC dba LeanDreams

FDA issued a warning letter to Lean Dreams LLC dba LeanDreams in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Vitals RX

FDA issued a warning letter to Vitals RX in September 2025 after reviewing their website and finding that the company marketed compounded semaglutide and tirzepatide products under a page title that referenced the FDA-approved brand name Ozempic, falsely implying equivalence with FDA-approved drugs. The FDA determined this claim misbranded the compounded products under FDCA sections 502(a) and 502(bb), constituting a prohibited act under section 301(a). The company was directed to immediately cease using the misleading language and to provide a written corrective response within 15 working days, with failure to comply risking seizure and injunction.

Healthy Living Clinic

FDA issued a warning letter to Healthy Living Clinic (Edgewater, CO) in September 2025 after reviewing its website and finding a false or misleading claim implying that its compounded semaglutide products are equivalent to FDA-approved brand-name drugs (Wegovy, Ozempic, Rybelsus). The claim violates FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

The HCG Institute

FDA issued a warning letter to The HCG Institute (Medford, NJ) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims falsely implied that compounded semaglutide is equivalent to FDA-approved products, constituting misbranding. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Expert Aesthetics

FDA issued a warning letter to Expert Aesthetics (owner Brenda Burr RN, MSN) in Mansfield, TX, after reviewing the website erasingage.com in August 2025. The agency found that marketing claims describing compounded semaglutide and tirzepatide as generics of Ozempic and Mounjaro falsely implied equivalence to FDA-approved products, constituting misbranding under FDCA sections 502(a) and 502(bb). FDA demanded cessation of the misleading language and a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

FWD Care, Inc. dba FWD

FDA issued a warning letter to FWD Care, Inc. dba FWD on September 9, 2025, after reviewing the company's website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro). The agency determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb) because compounded drugs are not FDA-approved and cannot lawfully be represented as the same as approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Jul 2025CRITICAL

cheaptrustedpharmacy.com

FDA issued a warning letter to cheaptrustedpharmacy.com, an online pharmacy based in the Turks & Caicos Islands, for selling unapproved and misbranded drugs to U.S. consumers, including unapproved semaglutide products (marketed as 'Semaglutide 0.5mg,' 'Semaglutide 1mg,' 'Semanize 4 Mg,' and 'Semanize 8 Mg'), unapproved lenalidomide, HIV combination therapy, and opioid tapentadol products. The products lack FDA-approved applications under section 505 of the FD&C Act and bear inadequate directions for use, constituting misbranding under section 502(f)(1). FDA demanded the site cease offering these products to U.S. consumers and respond within 15 working days, warning that failure to comply may result in seizure or injunction.

Jun 2025CRITICAL

www.buynetmeds.com

FDA issued a warning letter to www.buynetmeds.com, an India-based online pharmacy, for unlawfully selling unapproved and misbranded drugs to U.S. consumers, including tapentadol opioid products and semaglutide (GLP-1) products such as counterfeit Rybelsus tablets and injectable semaglutide under the brand 'Fitaro.' The products were sold without valid FDA approval and without requiring a prescription, violating multiple provisions of the FD&C Act. FDA demanded the site cease all sales of unapproved and misbranded drugs to U.S. consumers and respond within 15 working days, warning that failure to comply may result in seizure or injunction.

May 2025CRITICAL

www.peacefulmeds.com

FDA issued a warning letter to www.peacefulmeds.com for unlawfully selling unapproved and misbranded prescription drugs to U.S. consumers via the internet, including opioids (tramadol), benzodiazepines (diazepam/Valium), and injectable semaglutide (marketed under the Ozempic brand name) without requiring a prescription. The site's product descriptions made therapeutic claims establishing intended drug use while bypassing FDA approval and prescription requirements, violating multiple provisions of the FD&C Act. FDA demanded the site cease all sales of unapproved and misbranded drugs and respond within 15 working days with corrective steps. Failure to comply may result in seizure or injunction.

Apr 2025CRITICAL

www.24hreup.biz

FDA issued a warning letter to www.24hreup.biz, a Germany-based website, for selling unapproved and misbranded semaglutide drug products — marketed as 'Ozempic 0.5mg,' 'Ozempic 1mg,' and 'Rybelsus Semaglutide 14mg' — to U.S. consumers without a prescription and without FDA approval. The products violate the FD&C Act as unapproved new drugs and misbranded prescription drugs lacking adequate directions for use. FDA demands the site cease sales to U.S. consumers and respond within 15 working days, warning that failure to comply may result in seizure and injunction.

Feb 2025CRITICAL

USApeptide.com

FDA issued a warning letter to USApeptide.com (based in Germany) for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet. The site marketed these GLP-1 receptor agonists with claims referencing FDA-approved brand names (Ozempic, Wegovy, Rybelsus, Mounjaro) and human therapeutic uses, despite labeling them 'research use only' and 'not for human consumption.' FDA found the products to be unapproved new drugs lacking valid section 505 applications and misbranded because they lacked adequate directions for use and were dispensed without a prescription. FDA demanded cessation of sales to U.S. consumers and a written corrective response within 15 working days, warning that failure to comply may result in seizure and injunction.

Jan 2025CRITICAL

www.weightcrunchshop.com

FDA issued a warning letter to www.weightcrunchshop.com, a Hong Kong-based website, for selling unapproved and misbranded drugs to U.S. consumers, including counterfeit/unapproved semaglutide products ('Orsema 0.25 mg,' 'Orsema 0.50 mg'), genuine brand-name Ozempic offered without a prescription, and oxycodone tablets sold without a prescription. The site violated the FD&C Act by introducing unapproved new drugs into interstate commerce, failing to bear adequate directions for use, and dispensing prescription drugs without valid prescriptions. FDA demanded cessation of all such sales and a written corrective-action response within 15 working days, warning that failure to comply may result in seizure and injunction.

Summit Research Peptides

FDA issued a warning letter to Summit Research Peptides (Hoover, AL) on December 10, 2024, after reviewing the company's website and Facebook page and finding that products marketed as Semaglutide, Retatrutide, Cagrilintide, Tirzepatide, and Mazdutide were being sold as unapproved new drugs for human use despite 'Research Use Only' labeling. The agency found that product descriptions and social media posts established intended human therapeutic use — including claims about weight loss, glucose control, and cardiovascular health — in violation of FD&C Act sections 505(a) and 301(d). No FDA-approved applications are in effect for these products. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.

Swisschems

FDA issued a warning letter to Swisschems (New York, NY) on December 10, 2024, after reviewing their website and social media accounts and finding that they were selling unapproved Semaglutide and Retatrutide products in the United States. Despite labeling the products as 'research chemicals only,' FDA determined the marketing claims established intended human drug use, making them unapproved new drugs in violation of FD&C Act sections 505(a) and 301(d). FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure and injunction.

Prime Vitality, Inc. dba Prime Peptides

FDA issued a warning letter to Prime Vitality, Inc. dba Prime Peptides (Santa Barbara, CA) on December 10, 2024, after reviewing the company's website and social media accounts and finding that its Semaglutide and Retatrutide products were being marketed as drugs for human use despite 'research purposes only' disclaimers. The company's website, blog posts, Facebook, Instagram, and YouTube content made explicit disease-treatment and weight-loss efficacy claims, establishing intended human use and rendering the products unapproved new drugs under the FD&C Act. FDA found violations of sections 505(a) and 301(d) of the FD&C Act and warned that failure to correct may result in seizure or injunction. The company was required to respond within fifteen working days with corrective steps.

Veronvy

FDA issued a warning letter to Veronvy (Rancho Dominguez, CA) on December 10, 2024, regarding its 'Elily Veronvy' and 'Elily Veronvy 40+' products marketed as GLP-1-mimicking weight loss drops. The products were found to be unapproved new drugs making drug-intent claims (appetite suppression, gastric emptying, fat burning, and weight loss up to 52 lbs) and were misbranded because the labeling falsely claimed FDA approval via an 'FDA APPROVED' badge and explicit written statements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Sep 2024CRITICAL

Nomida.biz

FDA issued a warning letter to Nomida.biz on September 12, 2024, for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet without requiring a prescription. The site marketed these GLP-1 injectable products with claims of safety, effectiveness, and weight loss innovation, despite lacking FDA-approved drug applications for the specific formulations offered. FDA cited violations of the FD&C Act including introduction of unapproved new drugs and misbranding, and demanded corrective action within 15 working days, warning that failure to comply could result in seizure or injunction.

Aug 2024CRITICAL

AnuMed International, LLC

AnuMed International, LLC, a Phoenix-based drug manufacturer, received an FDA Warning Letter on August 20, 2024, citing multiple unapproved new drugs sold without FDA approval, including a 'Semaglutide Homeopathic Formula,' bio-identical hormone creams, and various supplement products making disease treatment claims. The company's products were also found to be misbranded—falsely implying FDA approval by labeling products as made in an 'FDA Approved Facility' or 'FDA registered facility'—and adulterated due to serious CGMP violations including failure to perform identity testing on components such as glycerin and ethanol. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Jun 2024CRITICAL

Ozempen.com

FDA issued a warning letter to Ozempen.com on June 24, 2024, for selling unapproved and misbranded semaglutide drug products ('4mg Semaglutide Pen' and '8mg Semaglutide Pen') to U.S. consumers over the internet without valid FDA-approved drug applications under section 505 of the FD&C Act. The site marketed these products as containing the 'same active ingredient as Ozempic, Rybelsus and Wegovy' while bypassing prescription requirements and omitting required safety warnings, including the black box warning for thyroid C-cell tumor risk. FDA demanded cessation of sales and a written corrective action response within 15 working days, warning that failure to comply could result in seizure and injunction.

Apr 2024CRITICAL

www.dashpct.com

FDA issued a warning letter to www.dashpct.com, a Malaysia-based website, for selling unapproved and misbranded semaglutide drug products — specifically 'Rybelsus 14mg' and 'Rybelsus 7mg' — to U.S. consumers over the internet without valid FDA-approved drug applications. The site falsely represented these products as FDA-approved while selling them without a prescription or licensed practitioner oversight, violating sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act. FDA demanded the site cease sales of unapproved and misbranded drugs and respond within 15 working days. Failure to comply may result in seizure and injunction.

Feb 2024CRITICAL

Synthetix Inc. DBA Helix Chemical Supply

FDA issued a warning letter to Synthetix Inc. DBA Helix Chemical Supply (Bronx, NY) in February 2024 after reviewing their website and finding unapproved Semaglutide and Tirzepatide products being sold for human use despite 'research use only' labeling. The products were deemed unapproved new drugs under FD&C Act sections 505(a) and 301(d), and misbranded under section 502(f)(1) for lacking adequate directions for use. FDA cited website claims referencing human dosing schedules, therapeutic effects, and explicit references to the branded drug Mounjaro as evidence of intended human use. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Feb 2024CRITICAL

US Chem Labs

FDA issued a warning letter to US Chem Labs (Miami, FL) in February 2024 after reviewing their website and finding they were selling Semaglutide, Tirzepatide, and Thymalin as unapproved new drugs intended for human use, despite labeling them 'research chemicals only' and 'not for human consumption.' The products were found to violate the FD&C Act as unapproved new drugs and misbranded drugs lacking adequate directions for use. FDA expressed particular concern about marketing Thymalin for use in children. The letter demands a written response within 15 working days and warns that failure to comply may result in seizure or injunction.

Oct 2023CRITICAL

www.gorillahealing.com

FDA issued a warning letter to www.gorillahealing.com for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet. The site marketed these prescription GLP-1 drugs without FDA-approved applications, without adequate directions for use, and without required safety warnings such as the black box warning for thyroid C-cell tumor risk. FDA demanded the company cease sales of these products and respond within 15 working days, warning that failure to comply could result in seizure and injunction.

Oct 2023CRITICAL