FDA WARNING_LETTER - MEDVi, LLC dba MEDVi - December 31, 2025

The FDA issued a Warning Letter to MEDVi, LLC dba MEDVi on February 20, 2026, following a December 2025 review of their website. The agency identified significant violations related to compounded semaglutide and tirzepatide drug products. MEDVi's website falsely represented itself as the compounder of these drugs and made misleading claims implying the compounded products were FDA-approved or evaluated for safety and effectiveness. Such claims included statements like "Same active ingredient as Wegovy® and Ozempic®" and "Same active ingredient as Mounjaro® and Zepbound®." These actions constitute misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), with the introduction of these misbranded products into interstate commerce being a prohibited act under section 301(a) of the FDCA. MEDVi is required to provide a written response within fifteen working days, detailing corrective actions. This includes identifying the actual entities compounding the products, providing sample labeling, and modifying or removing all false or misleading claims from their website. Failure to comply may result in further legal action.