Curex
FDA issued a warning letter to Curex, a Miami-based telehealth company, in September 2025 after reviewing its website and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims implied that Curex's compounded products were equivalent to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound, when compounded drugs are not FDA-approved. FDA cited these claims as misbranding violations and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (5)
Clinically proven success
Prescription weight loss with the same active ingredients as Mounjaro & Zepbound.
While we don't prescribe Ozempic, Wegovy, Zepbound, or Mounjaro directly, we may prescribe treatments containing the same active ingredients.
Clinically proven weight loss treatments
The same active ingredients as Ozempic or Mounjaro
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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