FDA warned MEDVi over compounded semaglutide and tirzepatide claims before New York Times profile
FDA called MEDVi's compounded GLP-1 labeling and brand claims misleading on Feb. 20; six weeks later, a New York Times profile described its growth to a projected $1.8 billion in 2026 sales.
The FDA sent MEDVi, LLC a warning letter dated Feb. 20, 2026, saying the company's website offered misbranded compounded semaglutide and tirzepatide products [1]. Six weeks later, on April 2, The New York Times profiled MEDVi, a telehealth company that markets compounded GLP-1s, reporting a projected $1.8 billion in 2026 sales [2].
The letter says the agency reviewed medvi.io in December 2025 [1]. It states that product labels pictured on the site carried the name "MEDVi," suggesting the company was the compounder of the drugs when it was not, and that this labeling is false or misleading under the Federal Food, Drug, and Cosmetic Act [1]. Federal regulations say a drug label showing a name without qualification represents that the named person is the sole manufacturer [1].
The FDA also cited two claims on the site: "Same active ingredient as Wegovy® and Ozempic®" and "Same active ingredient as Mounjaro® and Zepbound®" [1]. Wegovy and Ozempic are semaglutide products; Mounjaro and Zepbound are tirzepatide products. Compounded drugs are not FDA-approved, and the agency said the claims falsely imply that the products had been approved or evaluated for safety and effectiveness [1]. The letter said the products are "new drugs" not generally recognized as safe and effective for their labeled uses [1].
The FDA asked for a written response within 15 working days to its Office of Compounding Quality and Compliance, describing steps taken to fix the violations [1]. It asked MEDVi to identify the entities that produce the compounded products, provide sample labeling, and address other website claims that could be seen as false or misleading [1]. The letter said failure to adequately address the violations could lead to legal action, including seizure and injunction, and that the cited violations were "not intended to be an all-inclusive statement of violations that may exist" [1].
Matthew Gallagher, MEDVi's founder, told the Times he built the company using artificial intelligence services including ChatGPT, Claude, Grok, MidJourney and Runway, while CareValidate, a telehealth platform, and OpenLoop Health handled doctors, pharmacies, shipping and compliance [2]. The company had two full-time employees, Gallagher and his brother Elliot, along with contract engineers, account managers and outside agencies, the Times reported [2]. The Times said it was given access to MEDVi's financials to verify revenue and profits [2]. Gallagher had described the firm on LinkedIn as "the fastest growing company in history," a phrase he has since removed [2].
MEDVi reported 250,000 customers by the end of 2025, and its current homepage says "500,000+ MEDVi patients" [2]. On April 8, MEDVi said the FDA-cited website belonged to an affiliate marketing agency and that MEDVi had "never received a letter from the FDA" [2]. The warning letter is addressed to "MEDVi, LLC dba MEDVi" at a Newark, Delaware address, uses the help@medvi.io email address, and cites MEDVi-branded claims [1][2].
Separate reporting in April found more than 5,000 active Meta ads for "medvi," many running under apparently fabricated physician personas; the number fell to roughly 2,800 after questions were raised [2]. MEDVi's site fine print states: "Individuals appearing in advertisements may be actors or AI portraying doctors and are not licensed medical professionals" [2].
Why it matters for patients
Compounded semaglutide and tirzepatide are not FDA-approved products, even when they contain the same active ingredient as Ozempic, Wegovy, Mounjaro or Zepbound [1]. The FDA letter concerns how the products were labeled and promoted; it does not report a clinical finding that the compounded drugs were unsafe or ineffective, and no such finding appears in the record of the letter [1].
The letter points to a practical gap. A patient seeing a MEDVi label could not tell from the label alone which pharmacy made the drug [1]. The FDA asked the company to identify those producers, and that response has not been made public [1][2].
Federal rules on copying approved drugs have also tightened. The FDA determined the tirzepatide injection shortage was resolved on Dec. 19, 2024, and the semaglutide injection shortage was resolved on Feb. 21, 2025 [2]. Many sellers moved to "personalized" formulations that add ingredients such as vitamin B-12 and argue the result is not "essentially a copy" [2]. On April 1, 2026, the FDA said a compounded product combining semaglutide with another active ingredient such as vitamin B12 may still be "essentially a copy" unless a prescriber documents a patient-specific "significant difference" [2].
What happens next
The 15-working-day response window tied to the Feb. 20 letter has passed, and it has not been reported whether MEDVi submitted a written response [1]. The FDA has said it could pursue seizure or injunction if the violations are not addressed [1]. Also on April 10, MEDVi removed Dr. Ana Lisa Carr and Dr. Kelly Tenbrink from its website after a publication requested comment from both physicians [2].
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