FDA WARNING_LETTER - Levity Inc. dba Levity - December 31, 2025

The FDA issued a Warning Letter to Levity Inc. dba Levity on February 20, 2026, after reviewing their website, joinlevity.com, in December 2025. The letter addresses significant violations related to the company"s offering of compounded semaglutide and liraglutide drug products.

The main issues stem from the misbranding of these products. Levity’s website falsely suggests the company is the compounder of the drugs, and it makes misleading claims such as "The same ingredient as Ozempic® + Wegovy®" and "The power of Saxenda®." These statements imply FDA approval or evaluation for safety and effectiveness, which is not true for compounded drugs. Such false or misleading labeling and advertising constitute misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), and introducing these misbranded products into interstate commerce violates FDCA section 301(a).

Levity must take immediate corrective action. Within fifteen working days, the company is required to provide a written response outlining specific steps taken to address all violations and prevent recurrence. This includes identifying the actual producers of the compounded products, supplying representative labeling samples, and modifying or removing other false or misleading claims from their website. Failure to comply could lead to further legal action, including product seizure and injunction.