FDA WARNING_LETTER - FitRX, LLC dba Zealthy - December 31, 2025

The FDA issued a Warning Letter to FitRX, LLC dba FitRx on February 20, 2026, following a December 2025 review of their website, fitrxapp.com. The letter addresses significant violations concerning the promotion and sale of compounded semaglutide and tirzepatide drug products.The primary issues involve false and misleading claims that cause the products to be misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). FitRx’s website falsely suggests the company is the compounder of these drugs, despite not being so. Furthermore, claims implying that their compounded products are FDA-approved or have been evaluated for safety and effectiveness are misleading, as compounded drugs are not FDA-approved. These actions constitute a prohibited act under section 301(a) of the FDCA, involving the introduction of misbranded drugs into interstate commerce.FitRx is required to take immediate corrective action. The company must provide a written response to the FDA’s Office of Compounding Quality and Compliance within fifteen working days, detailing the specific steps taken to address these violations and prevent recurrence. This includes identifying the actual entities compounding the products, providing representative labeling samples, and modifying or removing all false or misleading claims from their website. Failure to comply may lead to legal action, including seizure or injunction.