FDA WARNING_LETTER - FitRX, LLC dba AM RX - March 01, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter on June 8, 2026, to FitRX, LLC, doing business as AM RX, following a review of the company"s website in March 2026. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning the marketing of compounded semaglutide and tirzepatide medications. The primary issues involve false and misleading claims that result in product misbranding. Specifically, the FDA found that AM RX’s website displayed labels suggesting the company was the actual manufacturer of the drugs when it was not. Additionally, the company compared its compounded products to brand-name medications like Ozempic and Wegovy, which falsely implied that these compounded versions were FDA-approved or had been evaluated for safety and effectiveness. Under the FD&C Act, these representations are prohibited as they involve the distribution of misbranded drugs in interstate commerce. To address these violations, the FDA requires AM RX to submit a written response within 15 business days detailing its corrective actions. The company must identify the actual producers of the compounded drugs, provide representative labeling, and modify or remove misleading website claims. AM RX is also responsible for investigating the root causes of these violations to prevent future non-compliance. Failure to rectify these issues may result in legal consequences, including product seizure or injunctions.