LyfeUnit / www.lyfeunit.com
FDA issued a warning letter to LyfeUnit (www.lyfeunit.com) on June 23, 2026, for selling unapproved and misbranded ketamine drug products to U.S. consumers via the internet without a valid FDA-approved drug application and without requiring a prescription. The site marketed injectable ketamine vials (Rotexmedica Ketamine 500mg/10ml) with claims referencing mental health treatments and anesthetic indications, in violation of sections 301, 502, 503, and 505 of the FD&C Act. FDA warned that failure to comply may result in seizure and injunction, and demanded a written corrective response within 15 business days.
Flagged claims (3)
Rotexmedica Ketamine 500mg/10ml, serves as a sole anesthetic for short diagnostic and surgical procedures not requiring muscle relaxation, such as those involving the eye, ear, nose, mouth, or dental extractions. Ketamine from Rotexmedica is also indicated for anesthesia induction before other general anesthetics or to supplement weaker agents like nitrous oxide.
Buy Rotexmedica Ketamine 500mg/10ml Vials | Mental Health Treatments
Mental Health Treatments
Required actions (3)
FDA requests that www.lyfeunit.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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