FDA warns MEDVi over misbranded compounded GLP-1 products
FDA told telehealth seller MEDVi that its website falsely suggested the company compounded its own semaglutide and tirzepatide, and that "same active ingredient as Wegovy" claims imply FDA approval that compounded drugs do not have [1].
The FDA sent a warning letter dated February 20, 2026 to MEDVi, LLC, a telehealth company based in Newark, Delaware, saying the compounded semaglutide and tirzepatide products sold on its website are misbranded drugs [1]. The agency said the site's labeling suggested MEDVi was the compounder of those drugs "when in fact it is not," and that marketing claims comparing the products to brand-name GLP-1s were false or misleading [1].
The letter came from the Office of Compounding Quality and Compliance within FDA's Center for Drug Evaluation and Research, signed by Acting Director Matthew J. Lash [1]. FDA said it reviewed the content at medvi.io in December 2025 [1].
What FDA objected to
Two problems are described. First, the compounded products pictured on the site carried labels reading "MEDVi," which FDA said implies the company made them [1]. The agency cited a regulation stating that a person's name on a drug label without qualification is a representation that the named person is the sole manufacturer, and that such a representation is false and misleading if the person is not the manufacturer [1].
Second, FDA flagged two specific claims on the site: "Same active ingredient as Wegovy® and Ozempic®" and "Same active ingredient as Mounjaro® and Zepbound®" [1]. The agency's response was blunt: "Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not" [1].
FDA gave MEDVi 15 working days to respond in writing, and asked the company to identify which entities actually produce the compounded products it sells, provide sample labeling, and address other claims that could be construed as misleading [1]. The letter warned that failure to fix the problems "may result in legal action without further notice, including, without limitation, seizure and injunction" [1]. FDA also noted the listed violations are "not intended to be an all-inclusive statement of violations" [1].
The company's growth and its response
Six weeks after the letter, on April 2, The New York Times profiled MEDVi as an example of an AI-built business, reporting a projected $1.8 billion in 2026 sales run by two full-time employees — founder Matthew Gallagher and his brother — plus contractors and outside agencies [2]. MEDVi reported 250,000 customers by the end of 2025, and its homepage later claimed "500,000+ MEDVi patients" [2].
In an April 8 statement, MEDVi said medvi.io belonged to an affiliate marketing agency and that MEDVi itself had "never received a letter from the FDA" [2]. The warning letter is addressed to "MEDVi, LLC dba MEDVi" and lists help@medvi.io as the contact email [1][2].
Trade and business press reporting also described more than 5,000 active Meta ads tied to MEDVi, many running under apparently fabricated physician personas with AI-generated video testimonials [2]. Gallagher told Business Insider that "maybe 30%" of the company's advertising ran through affiliates and that MEDVi discloses actor or AI portrayals of doctors, or does not use them at all [2]. After those questions were raised, the number of active ads dropped to roughly 2,800 [2].
Why it matters for patients
The core issue in the letter is transparency about who actually makes the drug in the vial. FDA says the site did not make clear who the compounder was [1]. For someone buying a compounded GLP-1 online, that means the manufacturing source — and the quality oversight behind it — may not be visible from the ordering page.
The "same active ingredient" framing is also central. FDA's position is that this wording suggests an approval or safety review that compounded drugs have not gone through [1]. Compounded semaglutide and tirzepatide are not FDA-approved products, and the agency's letter states plainly that they are not generally recognized as safe and effective for their labeled uses [1].
Context matters here too. FDA determined the tirzepatide injection shortage was resolved on December 19, 2024, and the semaglutide injection shortage on February 21, 2025 [2]. On April 1, 2026, FDA said a compounded product mixing semaglutide with another active ingredient such as vitamin B12 may still count as "essentially a copy" of an approved drug unless a prescriber documents a patient-specific significant difference [2].
Separately, OpenLoop Health — the clinician network MEDVi's site says provides its care — disclosed a breach in which a threat actor claimed to have taken records from about 1.6 million patients on January 7, 2026, with at least 68,160 affected individuals confirmed in Texas [2].
What happens next
MEDVi's written response to FDA was due within 15 working days of receipt of the February 20 letter [1]. Whether the company responded, and whether FDA takes further action such as seizure or injunction, is not stated in the available sources.
Images from the sources
Sources
Semaglutides.org is for information only and is not medical advice. Always talk to a licensed healthcare provider about your own care. Some links to telehealth services are affiliate links, labeled where they appear.