ASN-LABS
FDA issued a warning letter to ASN-LABS (Honolulu, HI) in September 2025 after reviewing their website and finding they were selling compounded retatrutide and semaglutide products unlawfully. The compounded retatrutide products were cited as unapproved new drugs and misbranded drugs because retatrutide does not appear on the 503A or 503B bulks lists and is not an FDA-approved drug component. Additionally, ASN-LABS' website claims about compounded semaglutide were found to be false or misleading because they implied equivalence to FDA-approved products (Wegovy, Ozempic, Rybelsus). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (2)
Semaglutide is the generic drug in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.
The same active ingredient as Wegovy and 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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