FDA WARNING_LETTER - D&H Medical Services - March 01, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to D&H Medical Services on June 8, 2026, following a review of the company’s website conducted in March 2026. The FDA’s investigation focused on the marketing of compounded drug products, specifically those containing semaglutide and tirzepatide. The primary violation identified was the use of false and misleading claims. D&H Medical Services advertised its products using phrases such as "Same ingredient as Ozempic®" and "Same ingredient as Mounjaro®." According to the FDA, these statements incorrectly imply that the compounded drugs are identical to, or have received the same safety and effectiveness evaluations as, FDA-approved medications. Because compounded drugs are not FDA-approved, such representations constitute misbranding under the Federal Food, Drug, and Cosmetic Act. To address these violations, the company is required to submit a written response to the FDA within fifteen business days. This response must include a detailed plan for correcting the misleading claims, identifying the sources of their compounded drugs, and providing samples of current labeling. Failure to rectify these issues may lead to legal action, including product seizures or injunctions.