SimpleRx
FDA issued a warning letter to SimpleRx (Bellevue, KY) in September 2025 after reviewing their website and finding that compounded semaglutide and tirzepatide products were marketed using brand names (Ozempic, Zepbound) in a manner that falsely implied equivalence to FDA-approved drugs. These claims were found to misbrand the compounded products under FDCA sections 502(a) and 502(bb). FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
Tirzepatide (generic Zepbound)
Tirzepatide (Zepbound)
Semaglutide (Ozempic)
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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