FDA WARNING_LETTER - GenLabMeds - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to GenLabMeds following a review of its website in August 2025. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA) related to the sale of compounded drugs, specifically retatrutide, semaglutide, and tirzepatide. The FDA found that GenLabMeds is distributing unapproved new drugs and misbranded products. Specifically, retatrutide does not qualify for legal compounding exemptions under sections 503A or 503B because it is not a component of an FDA-approved drug, lacks an official quality monograph, and is not on the approved bulk drug substances lists. Additionally, the drug is misbranded because it lacks adequate directions for safe use by consumers. The letter also highlights false and misleading marketing claims. The company’s website incorrectly suggested its compounded products are identical to brand-name medications like Ozempic, Wegovy, and Mounjaro. Furthermore, the company claimed there was an FDA-approved dosing schedule for retatrutide, despite the drug having no FDA approval. These claims mislead consumers regarding the safety and approval status of the products. GenLabMeds is required to take immediate action to correct these violations and must provide a written response to the FDA within 15 working days. This response must detail the specific steps taken to address the issues and prevent their recurrence. Failure to comply may lead to legal action, including product seizures or injunctions.