FDA cites 25 companies over claims about compounded semaglutide and tirzepatide

The FDA has warned 25 telehealth and compounding businesses that their websites mischaracterize compounded semaglutide and tirzepatide, according to warning letters dated June 8, 2026, and posted publicly on June 16, 2026 ^[3]. Companies named include Maximus Health, OrderlyMeds, Clover Meds, RoenRx, FitRx, Eden Health International and HydraMed IV, among others ^[3].

Reviewers examined company websites in March 2026 and flagged wording that, in the agency's view, suggests the compounded products carry FDA approval or have been checked for safety and effectiveness ^[1][2]. Altru Telehealth's site, for example, described "Compounded semaglutide combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12" and said compounded products offer "the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy" ^[1]. The same site called its compounding pharmacies "FDA approved" — a designation the FDA says does not exist for pharmacies or outsourcing facilities ^[1].

A second letter, to FITISH, took issue with product images: the compounded drugs pictured on fitish.com carried a label reading "FITISH," which the agency said implies the company made the drugs when it did not ^[2]. That letter also questioned statements that "Semaglutide is the active ingredient in ozempic" [sic] and "Tirzepatide is the active ingredient in Mounjaro® and Zepbound®," noting that compounded drugs are not FDA-approved ^[2].

The agency classifies the products as misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, and calls shipping them in interstate commerce a prohibited act under section 301(a) ^[1][2]. Each recipient must reply in writing to the Office of Compounding Quality and Compliance within 15 business days, spelling out corrections and steps to keep the problems from returning ^[1][2]. The letters, signed by acting office director Matthew J. Lash, say unresolved violations could bring seizure or an injunction ^[1][2].

Compounded drugs remain legal in limited situations — during a shortage, or for a patient who needs a customized formula — but they skip the premarket review that brand-name products undergo for safety, effectiveness and manufacturing quality ^[3]. The FDA has separately cautioned consumers about dosing mistakes, counterfeit products, storage problems and quality issues with unapproved GLP-1-type drugs ^[3].

Nothing in the letters says the FDA tested these products and found them unsafe or ineffective; the cited violations concern marketing language ^[1][2]. The letters also do not bar the companies from selling compounded drugs where the law allows ^[3]. How the 25 companies responded has not been disclosed.

Why it matters for patients

Adults comparing a brand-name GLP-1 such as Ozempic, Wegovy, Mounjaro or Zepbound with a compounded alternative often get their first information from a seller's website. The FDA's objection is that specific phrases on those sites could lead a reader to believe a compounded product went through the same approval process as the brand version, or that it delivers identical results for less money ^[1][2][3]. The agency says compounded products have not been evaluated for safety, effectiveness or quality ^[1].

Two practical points: the letters target company advertising, not patients, and they change nothing about whether a compounded prescription is lawful. Anyone weighing the two options still faces the question the FDA flagged — whether a compounded version performs like the approved drug has not been established by the agency ^[1][3].

What happens next

The 25 recipients have 15 business days from receipt to file written responses describing what they fixed and how they will prevent repeats ^[1][2]. The FDA has not said when it will act on those replies or what enforcement, if any, would follow. Any further steps — additional letters, seizures or court action — have not been announced ^[1][2].