Which specific FDA warning letters name compounding pharmacies that marketed compounded tirzepatide, and what violations were cited?
Executive summary
The FDA issued warning letters in September 2025 that explicitly name multiple online sellers and compounding pharmacies marketing compounded tirzepatide, including GLP‑1 Solution and Healthy Male, and has publicly flagged many others such as Hims, Hers, DirectMeds, Aequita Pharmacy, and ProRx in its enforcement activity and reporting [1] [2] [3] [4] [5]. The violations cited across these letters cluster around unapproved new‑drug marketing, false or misleading promotional claims that imply parity with FDA‑approved products, misbranding, interstate distribution of unapproved products, and, in some facility cases, sterility and manufacturing quality concerns [1] [2] [5] [4].
1. Which warning letters name compounding pharmacies marketing tirzepatide
The FDA warning letter released for the website GLP‑1 Solution explicitly notes that the site offered compounded tirzepatide among other GLP‑1 products after an August 2025 review, putting that entity on notice in writing [1]. A separate FDA warning letter to Healthy Male likewise documented that the company’s website offered compounded tirzepatide and identified specific promotional claims that the agency judged false or misleading [2]. Media and regulatory summaries published alongside the FDA correspondence identify other named entities receiving letters or cited in enforcement summaries, including online telehealth and pharmacy platforms Hims and Hers, DirectMeds, and licensed compounding pharmacies such as Aequita Pharmacy and ProRx; the industry and patient‑safety trackers attribute formal warning letters and associated recalls or notices to these names [3] [4] [5].
2. The violations the FDA cites — statutory framing and recurring themes
Across the letters the agency consistently frames the conduct as introducing unapproved new drugs into interstate commerce (violating section 505(a) and section 301(a) of the FDCA) and marketing misbranded products under sections 502(a), 502(bb), and 502(f) — essentially saying these compounded GLP‑1 products lack FDA approval, bear false or misleading labeling or advertising, and in many instances lack adequate directions for safe use [1] [2]. The FDA repeatedly flagged language that implies the compounded formulations are “the same” as branded, FDA‑approved drugs or are “clinically proven” equivalents, finding such claims inherently false or misleading because the compounded products have not undergone FDA review for safety, effectiveness, or quality [6] [7] [5].
3. Quality, sterility and safety problems flagged in facility‑focused letters
Beyond marketing claims, some FDA letters and recalls tied to these actions point to manufacturing and sterility problems that heighten patient risk: summaries note mass recalls of compounded semaglutide and tirzepatide where sterility assurance was lacking, and ProRx was publicly linked to recall activity for more than 15,000 vials due to sterility concerns [4]. The agency has also warned that some products are fraudulently labeled “for research” or “not for human consumption” while being sold with dosing instructions for human use — a label‑fraud pattern the FDA has called out in its safety communications [8].
4. Scope: dozens of letters, enforcement context, and limits of public reporting
The September 2025 sweep included more than 50 warning letters to GLP‑1 compounders and online sellers, the FDA and legal observers report, and the agency continues to publish letters as investigations proceed; many letters target similar promotional language and the same statutory violations [5] [6]. Public summaries from trade and patient‑safety outlets list named recipients and linked recalls, but the complete inventory and full text of every letter are published incrementally by the FDA and are the authoritative source for precise allegations in each case [5] [4]. Reporting also shows earlier FDA policy flexibility tied to the shortage status of branded tirzepatide that narrowed over 2024–2025, which contextualized earlier compounding activity but does not absolve the misbranding or quality violations the agency cited once discretion ended [9].
5. Bottom line: specific names and the common infractions
Concrete, individually published FDA warning letters naming compounding sellers of tirzepatide include GLP‑1 Solution and Healthy Male (each cited for marketing compounded tirzepatide and making false or misleading claims) and government and watchdog summaries associate Hims, Hers, DirectMeds, Aequita Pharmacy, and ProRx with formal warnings or recalls relating to compounded GLP‑1 products; the violations commonly cited are marketing unapproved new drugs, misbranding via false/misleading promotion that implies equivalence to FDA‑approved GLP‑1 drugs, interstate distribution in violation of the FDCA, and in several facility actions, sterility or manufacturing quality failures [1] [2] [3] [4] [5] [8].