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.
Flagged claims (3)
The power of Saxenda®
The same ingredient as Ozempic® + Wegovy®
The compounded semaglutide and liraglutide products displayed on your website identify "Levity" on the pictured label, suggesting Levity is the compounder of those drugs when in fact it is not.
Required actions (5)
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Identifying the entities that produce the compounded products offered on your website;
Providing a representative sample of labeling for such products;
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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