FDA WARNING_LETTER - PharmaZee - December 31, 2025

The FDA issued a Warning Letter to PharmaZee on February 20, 2026, following a December 2025 review of its website, pharmazee.co. The review revealed that PharmaZee is offering compounded semaglutide and tirzepatide drug products with significant violations. The primary issues involve false and misleading claims concerning these products, leading to misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA) sections 502(a) and 502(bb), and introducing misbranded products into interstate commerce, a prohibited act under section 301(a).

Specifically, PharmaZee’s website falsely suggests it is the compounder of these drugs. Additionally, claims such as "clinically proven medications," "proven prescription medications," and "Same active ingredient as Ozempic® and Wegovy®" are misleading. Compounded drugs are not FDA-approved, and these claims incorrectly imply the products have been evaluated for safety and effectiveness.

PharmaZee is required to take immediate action. Within fifteen working days, the company must provide a written response to the FDA’s Office of Compounding Quality and Compliance. This response needs to detail specific steps taken to address all violations and prevent recurrence. Required information includes identifying the actual entities compounding the products, providing representative labeling, and modifying or removing false or misleading website claims. Failure to adequately respond could lead to further legal action, including product seizure and injunction.