FDA WARNING_LETTER - Get.Fit.Medical, LLC dba Get.Fit.Medical - August 31, 2025

The FDA issued a warning letter to Get.Fit.Medical on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Get.Fit.Medical was offering compounded drug products such as sildenafil, tadalafil, semaglutide, and tirzepatide. The FDA identified that claims made about these products were false or misleading, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These violations result in the products being misbranded and their introduction into interstate commerce constitutes a breach of section 301(a) of the FDCA.

The FDA highlighted that compounded drugs are not FDA-approved, and the claims on Get.Fit.Medical"s website implied equivalence to FDA-approved products, which is misleading. The letter serves as a notice of these concerns and requires the company to take immediate corrective actions. Get.Fit.Medical must cease using misleading language and provide a written response within 15 working days to the Office of Compounding Quality and Compliance. This response should detail the steps taken to rectify the violations and prevent future occurrences. Failure to comply may lead to legal actions, including product seizure and injunctions. The FDA also warned that misbranded products might be detained or refused entry into the U.S. market.