FDA WARNING_LETTER - Master - August 31, 2025

The FDA issued a Warning Letter to Master Pharmaceuticals Group on September 9, 2025, following a review of their website in August 2025. The FDA identified that the company was offering compounded drug products, specifically semaglutide and tirzepatide, with claims that were deemed false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggested that the compounded products were equivalent to FDA-approved drugs, which they are not, leading to their classification as misbranded. This misbranding constitutes a violation of section 301(a) of the FDCA, which prohibits the introduction of such products into interstate commerce.

The FDA has mandated that Master Pharmaceuticals Group take immediate corrective actions. These include ceasing the use of misleading language on their website and ensuring compliance with all federal regulations. The company must submit a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions, including product seizure and injunctions. The FDA also warned that if the company operates outside the U.S., their products could be detained or refused entry into the country. The letter underscores the company"s responsibility to ensure their operations align with federal law and FDA regulations.