FDA WARNING_LETTER - Curex - August 31, 2025

The FDA issued a warning letter to Curex, located at 777 Brickell Ave, Miami, FL, on September 9, 2025, following a review of their website in August 2025. The review revealed that Curex offers compounded drug products, specifically semaglutide and tirzepatide, with claims that are deemed false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the compounded products are equivalent to FDA-approved drugs, which they are not, resulting in the products being misbranded and their introduction into interstate commerce violating section 301(a) of the FDCA.

The FDA requires Curex to take immediate corrective actions, including ceasing misleading advertising and ensuring compliance with federal regulations. Curex must provide a written response within 15 working days detailing the steps taken to address the violations and prevent future occurrences. Failure to comply may lead to legal actions, such as product seizure or injunctions. The letter also advises that if Curex believes their products are not in violation, they should provide supporting information for consideration. Correspondence should be directed to the Office of Compounding Quality and Compliance.