CRITICALGLP-1 / Weight LossFDA Warning Letter · February 20, 2026

MEDVi, LLC dba MEDVi

Atlas ID: 2026-02-fda-medvi-llc-dba-medvi-bh0obu

FDA issued a warning letter to MEDVi, LLC dba MEDVi on February 20, 2026, after reviewing its website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The agency found that MEDVi's website falsely implied the company was the compounder of these drugs (when it was not) and that claims comparing its products to FDA-approved brand-name drugs (Wegovy, Ozempic, Mounjaro, Zepbound) misleadingly implied FDA approval or evaluation for safety and effectiveness. 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 act could result in seizure or injunction.

Flagged claims (3)

Same active ingredient as Wegovy® and Ozempic®.

FDA trademark misuse · implied-fda-approval-via-brand-comparison

The compounded semaglutide and tirzepatide products displayed on your website identify "MEDVi" on the pictured label, suggesting MEDVi is the compounder of those drugs when in fact it is not.

Other · false-manufacturer-identity

Same active ingredient as Mounjaro® and Zepbound®.

FDA trademark misuse · implied-fda-approval-via-brand-comparison

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.

Response required · 15 days

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)].

Claim removal

Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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