FitRX, LLC dba FitRx
FDA issued a warning letter to FitRX, LLC dba FitRx (New York, NY) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the FitRx label appearing on product images implies FitRx is the compounder when it is not, and (2) website claims linking their compounded products to FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro) falsely imply FDA approval or evaluation for safety and effectiveness. Both violations constitute misbranding under FDCA sections 502(a) and 502(bb), and FitRx was given 15 working days to respond with corrective steps or face potential seizure and injunction.
Flagged claims (3)
we can ship semaglutide, the main active ingredient in Wegovy and Ozempic, or Tirzepatide, the main active ingredient in Zepbound and Mounjaro
The compounded semaglutide and tirzepatide products displayed on your website identify "FitRx" on the pictured label, suggesting FitRx is the compounder of those drugs when in fact it is not.
semaglutide (active ingredient in Wegovy) or tirzepatide (active ingredient in Zepbound)
Required actions (3)
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)].
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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