FDA WARNING_LETTER - Remedy Meds - August 31, 2025

The FDA issued a Warning Letter to Remedy Meds on September 9, 2025, following a review of their website in August 2025. The inspection revealed that the company offers compounded drug products, including semaglutide and tirzepatide, with claims that are false or misleading. These actions violate sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), resulting in the products being misbranded. Consequently, the introduction of these products into interstate commerce is prohibited under section 301(a) of the FDCA.

The FDA highlighted that the claims on Remedy Meds" website imply equivalence to FDA-approved products, which is misleading since compounded drugs are not FDA-approved. The letter emphasizes that these violations are not exhaustive, and the company is responsible for investigating and addressing all potential violations to ensure compliance with federal law.

Remedy Meds is required to take immediate corrective actions, such as ceasing misleading claims, and must provide a written response to the FDA"s Office of Compounding Quality and Compliance within 15 working days. This response should outline the steps taken to rectify the violations and prevent recurrence. Failure to comply may lead to legal actions, including product seizure and injunctions. The FDA also warns that misbranded products could face detention or refusal if imported into the U.S.