FDA WARNING_LETTER - Refills Health, LLC dba Refills Health - December 31, 2025

A Warning Letter was issued by the U.S. Food and Drug Administration (FDA) to Refills Health, LLC dba Refills Health on February 20, 2026, following a December 2025 review of its website, refills.com. The FDA identified significant violations concerning the company"s offering of compounded semaglutide drug products.

The primary issues cited involve the misbranding of these compounded drugs under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). Refills Health"s website contained false or misleading claims, specifically by depicting "Refills Health" on product labels, falsely implying that the company itself was the compounder of the drugs when it is not. Furthermore, the website made unsubstantiated claims such as "clinically proven" and "the same active ingredient found in certain FDA approved treatments." These statements falsely suggest that the compounded products have received FDA approval or been evaluated for safety and effectiveness, which is not the case for compounded drugs. Introducing or delivering these misbranded products into interstate commerce constitutes a prohibited act under section 301(a) of the FDCA.

Refills Health is required to take immediate action to address these violations. The company must provide a written response to the FDA within fifteen working days, detailing specific corrective steps. This includes identifying the actual entities that produce the compounded products, supplying representative labeling samples, and either modifying or removing the false and misleading claims from their website. Failure to comply may lead to further legal action.