FDA WARNING_LETTER - Alan Health Technologies Inc. dba Alan - December 31, 2025

The FDA issued a Warning Letter to Alan Health Technologies Inc. (dba Alan) on February 20, 2026, following a December 2025 review of their website, alanmeds.com. The agency identified significant violations related to the offering of compounded semaglutide and tirzepatide drug products.

The primary issue is the misbranding of these compounded drug products. Alan"s website displayed labels for these products suggesting that "Alan" was the compounder, which is a false or misleading representation, as the company does not perform the compounding. This misrepresentation renders the products misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), and their introduction into interstate commerce is a prohibited act under section 301(a) of the FDCA.

Alan is required to take immediate corrective action. Within fifteen working days, the company must provide a written response to the FDA"s Office of Compounding Quality and Compliance, detailing specific steps to address these violations and prevent recurrence. This includes identifying the actual producers of the compounded products, supplying representative labeling samples, and modifying or removing any other false or misleading claims from their website. Failure to adequately address these concerns may result in further legal action.