Have there been recent enforcement actions or warning letters about compounded GLP-1 or GIP/GLP-1 products?
Executive summary
The FDA and state and private actors have recently escalated enforcement and oversight of compounded GLP‑1 and GIP/GLP‑1 products: federal warning letters numbering roughly 50–60 were posted in September 2025 targeting telehealth platforms, online sellers and compounders for marketing unapproved or misbranded compounded GLP‑1 products (semaglutide, tirzepatide and others) [1] [2] [3]. The agency has also issued facility-level warning letters and created a “green list” to police imported GLP‑1 active ingredients amid reports of dosing errors, unapproved salt forms and hundreds of adverse events tied to compounded products [4] [5] [6].
1. FDA’s broad September 2025 sweep: a new front in online drug advertising enforcement
In mid‑September 2025 the FDA publicly posted more than 50 warning letters aimed largely at telehealth companies, online sellers and wellness clinics that marketed compounded GLP‑1 products with misleading claims — for example, suggesting those products were equivalent to FDA‑approved brand drugs — and cited “unlawful sale of unapproved and misbranded drugs to United States consumers over the internet” [1] [2]. Coverage and legal briefs put the total at roughly 55–60 letters, and the letters demanded immediate corrective action or face seizure or injunction [3] [2].
2. Facility and manufacturing enforcement: warning letters and recalls tied to outsourcing pharmacies
The FDA’s actions are not limited to advertising. The agency has issued facility‑level warning letters to registered 503B outsourcing facilities after inspections found cGMP violations and adulterated compounded GLP‑1 products; those letters and related recalls highlight concerns about large‑scale manufacturing problems and contaminated or misbranded batches [5] [7]. The agency has also warned that dosing inconsistencies and use of unapproved salt forms (e.g., semaglutide sodium/acetate) are safety hazards [6] [4].
3. Why enforcement accelerated: shortage rules, declaratory orders and “essentially a copy” doctrine
A key inflection point was the end of declared shortages for semaglutide and tirzepatide in early 2025. While FDA temporarily allowed compounding during shortages, once those shortages were resolved the agency gave 503A pharmacies 60 days and outsourcing facilities longer to wind down compounding that produced “essentially a copy” of an approved product; after those deadlines the agency moved to enforce advertising and manufacturing rules [8] [9] [10]. Legal friction followed: manufacturers and trade groups have used litigation and cease‑and‑desist letters alongside FDA enforcement [10] [5].
4. Patient‑safety thread: adverse events, adulterated imports, and the green list
Regulators warn that compounded GLP‑1s have produced hundreds of adverse event reports and that imported, uninspected APIs have flooded the market, sometimes labeled “for research” but marketed for human use. The FDA launched a “green list” of inspected API suppliers and framed the import problem as a threat requiring border action to stop illegal foreign GLP‑1 ingredients [6] [4] [11]. Reports cite dosing errors and hospitalizations tied to these unapproved compounded products [4] [6].
5. Multiple enforcement vectors: federal letters, state guidance, manufacturer litigation
Beyond FDA letters, states and brand manufacturers have acted: state attorneys general issued warnings about deceptive conduct by compounders, boards of pharmacy issued FAQs to regulate local practice, and manufacturers like Novo Nordisk and Eli Lilly have initiated lawsuits and mass cease‑and‑desist campaigns and private legal pressure against compounders [12] [10] [5]. Industry trackers and law firms describe a mix of regulatory action, litigation and commercial enforcement [2] [13].
6. Competing perspectives and implicit agendas
Regulators frame their campaign as protecting patients from unsafe, unapproved drugs and counterfeit APIs [4] [6]. Compounders and some telehealth firms have argued that they filled unmet demand during shortages and that some compounding is permissible under narrow statutory exceptions; litigation over those boundaries continues [8] [9]. Drugmakers have an economic incentive to curb copycat supply and have filed hundreds of cease‑and‑desist letters and lawsuits — an enforcement dynamic that overlaps with, but is not identical to, FDA public‑health motives [5] [10].
7. Practical takeaway for clinicians and consumers
Available reporting recommends that clinicians avoid unapproved compounded GLP‑1 products unless there is a documented, patient‑specific medical need that complies with Section 503A/503B limits, and that consumers insist on FDA‑approved formulations or verify a compounder appears on the FDA’s inspected lists and avoids unapproved salts or “research‑only” labels marketed to patients [6] [4] [8]. The FDA requires firms to respond to warning letters within 15 working days or face legal action [7].
Limitations: reporting is drawn from recent FDA postings, industry legal updates and reporting outlets; available sources do not offer exhaustive lists of every warning letter or every adverse event, and litigation outcomes remain in flux [2] [5].