ybycmeds – FDA Warning Letter, Aug 31, 2025

The FDA issued a warning letter to YBYC Meds, located at 6420 Inducon Dr. W, Sanborn, NY, on September 9, 2025, following a review of their website in August 2025. The inspection revealed that YBYC Meds was marketing compounded drug products, specifically semaglutide and tirzepatide, with misleading claims. These claims suggested that their compounded products were equivalent to FDA-approved drugs like Ozempic, Wegovy, Mounjaro, and Zepbound, which is not the case. This constitutes a violation under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), leading to the products being misbranded and introduced into interstate commerce unlawfully.

The FDA requires YBYC Meds to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must provide a written response to the Office of Compounding Quality and Compliance within 15 working days, detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions such as product seizure or injunctions. The letter serves as a notification of the FDA"s concerns and offers YBYC Meds an opportunity to address the issues. If the company believes their products are compliant, they must provide supporting information for FDA consideration. Correspondence should be directed to the FDA with a clear subject line indicating it is a response to the warning letter.