FDA WARNING_LETTER - Genesis Health International Inc. dba Genesis - December 31, 2025

The FDA issued a Warning Letter to Genesis Health International Inc. dba Genesis on February 20, 2026, following a December 2025 review of their website, trygenesis.com. The letter identified significant violations related to the marketing of compounded semaglutide and tirzepatide drug products. The primary issues involve misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA). Genesis's website falsely implied the company was the compounder of these drugs, and made deceptive claims such as "Contains the same active ingredient as Ozempic® and Wegovy®" and "Same active ingredient as Mounjaro®." These statements falsely suggested the compounded products were FDA-approved or had undergone similar safety and effectiveness evaluations, which they have not. These actions constitute misbranding under FDCA sections 502(a) and 502(bb), with their introduction into interstate commerce violating section 301(a). The FDA mandates immediate corrective action. Within fifteen working days, Genesis must provide a written response detailing steps taken to address these violations and prevent recurrence, including identifying actual product compounders, providing sample labeling, and either removing or modifying all false or misleading website claims. Failure to comply could lead to legal action, including product seizure and injunction.