ybycmeds
FDA issued a warning letter to ybycmeds (Sanborn, NY) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound. The claims were found to misbrand the products under FDCA sections 502(a) and 502(bb), constituting prohibited interstate commerce under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (4)
Semaglutide Compound 10mg vial - similar to Ozempic or Wegovy
Semaglutide for weight loss - Prefilled Syringes, similar to Ozempic or Wegovy
Tirzepatide Peptide 60mg vial - similar to Mounjaro and Zepbound
Tirzepatide for weight loss - Prefilled Syringes, similar to Mounjaro and Zepbound
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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