Refills Health, LLC dba Refills Health
FDA issued a warning letter to Refills Health, LLC (dba Refills Health) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide products. The website falsely identified Refills Health as the compounder of the drugs on product labels, and made claims implying FDA approval or clinical validation for products that have not been FDA-approved. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (2)
clinically proven
the same active ingredient found in certain FDA approved treatments
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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