FDA WARNING_LETTER - Clover Meds LLC dba Clover Meds - March 01, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Clover Meds LLC, doing business as Clover Meds, following a review of the company’s website in March 2026. The FDA identified significant violations regarding the marketing and labeling of compounded semaglutide and tirzepatide drug products. The primary issues involve false and misleading representations that violate the Federal Food, Drug, and Cosmetic Act. Specifically, the company’s website displays product labels suggesting Clover Meds is the manufacturer when it is not. Furthermore, the company claims its products are sourced from “FDA-licensed facilities.” The FDA clarified that this terminology is deceptive because the agency does not license or approve compounding pharmacies or their specific compounded products. These misrepresentations cause the drugs to be classified as misbranded under sections 502 and 301 of the Act. To achieve compliance, Clover Meds is required to investigate the root causes of these violations and implement corrective actions. The company must provide a written response within 15 business days outlining its plan to resolve the issues. Required actions include identifying the actual producers of the drugs, providing representative labeling samples, and removing all misleading claims from their website. Failure to address these violations may result in legal action, such as product seizures or injunctions.