PharmaZee
FDA issued a warning letter to PharmaZee (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified PharmaZee as the compounder of the drugs and made claims implying FDA approval or clinical validation for unapproved compounded products. FDA cited misbranding violations under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (4)
The compounded semaglutide and tirzepatide products displayed on your website identify "PharmaZee" on the pictured label, suggesting PharmaZee is the compounder of those drugs when in fact it is not.
Same active ingredient as Ozempic® and Wegovy®
clinically proven medications
proven prescription medications
Required actions (5)
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Identifying the entities that produce the compounded products offered on your website;
Providing a representative sample of labeling for such products;
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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