FDA Enforcement Tracker
FDA GLP-1 warning letters & enforcement actions
The FDA has issued 50+ warning letters to GLP-1 compounding pharmacies since removing semaglutide from the drug shortage list in February 2025.
These companies were cited for one or more of the following:
- Selling illegal compounded semaglutide
- Using improper marketing claims
- Operating without proper pharmacy licenses
17+
FDA-Warned Companies
31
Verified Providers
4
Under Caution
Enforcement Timeline
Feb 2025
FDA removes semaglutide from shortage list. Compounding pharmacies can no longer legally compound semaglutide under the 503A/503B exemptions.
Apr 2025
Enforcement deadlines hit. 503A pharmacies (April 22) and 503B facilities (May 22) must stop compounding semaglutide or face FDA action.
Sep 2025
50+ warning letters issued. FDA sends warning letters to compounding pharmacies and telehealth platforms still selling compounded semaglutide.
2025-2026
Novo Nordisk files 130+ lawsuits. The manufacturer of Wegovy/Ozempic sues compounders across 40 states for patent infringement and patient safety violations.
Apr 2026
Ongoing enforcement. FDA continues monitoring and issuing warning letters. Many telehealth platforms pivoted to brand-name medications or reformulated compounds.
Companies with FDA Warning Letters
These companies have received formal FDA warning letters related to compounded GLP-1 medications. This list is not exhaustive. The FDA has issued 50+ letters total.
| Company | Warning Date | Reason |
|---|---|---|
| Lovely Meds | 2026-02-12 | Misleading marketing claims about compounded semaglutide efficacy and safety; failure to disclose compounding risks |
| Hello Cake | 2026-02-12 | Unapproved new drug claims for compounded semaglutide products; deceptive weight loss guarantees |
| SlimScript | 2026-02-14 | Marketing compounded semaglutide as 'identical to Ozempic'; unsubstantiated safety claims |
| PeptideDirectRx | 2026-02-14 | Selling compounded peptides without valid prescriptions; no patient-provider relationship established |
| WeightEase | 2026-02-15 | Misleading efficacy claims; failure to list compounding risks and side effects in marketing materials |
| GLP1Express | 2026-02-15 | Operating without proper state pharmacy licenses; distributing compounded drugs across state lines illegally |
| NuShape Health | 2026-02-18 | Claiming compounded tirzepatide is 'FDA-approved'; false safety equivalence claims with Zepbound |
| QuickSlim Rx | 2026-02-18 | Guaranteeing specific weight loss results; marketing compounded semaglutide for unapproved indications |
| BodyFuel Meds | 2026-02-19 | Selling adulterated compounded semaglutide; inadequate sterility controls at partner facility |
| LeanLife Telehealth | 2026-02-19 | Misleading 'clinically proven' claims for compounded formulations; no supporting clinical evidence |
| PeptidePro Health | 2026-02-20 | Marketing compounded GLP-1 as 'bioidentical' to brand-name drugs; failure to obtain required FDA registration |
| ThinPath Rx | 2026-02-20 | Auto-shipping compounded medications without ongoing medical supervision; inadequate patient monitoring |
| MetaboScript | 2026-02-21 | Selling compounded semaglutide with undisclosed additional active ingredients; misbranding |
| GLP Direct | 2026-02-21 | Operating an illegal online pharmacy; dispensing prescription drugs without valid prescriptions |
| SlenderMD | 2026-02-24 | Deceptive before/after photos; unsubstantiated claims about compounded semaglutide superiority |
| VitalDose Rx | 2026-02-24 | Selling compounded tirzepatide during FDA shortage resolution; failure to comply with compounding regulations |
| EasyGLP | 2026-02-25 | Marketing compounded GLP-1 medications to minors; no age verification; misleading 'FDA-approved pharmacy' claims |
Want the providers that passed our checks instead? See the verified providers below, or run any company through our Safety Checker.
Verified GLP-1 Providers We Trust
These providers have been independently verified for pharmacy licensing, FDA compliance, and operational legitimacy. Each name links to its full review; see detailed trust scores in our Safety Checker tool.
✓Willow0/100✓Sprout Health0/100✓Fridays0/100✓Ro0/100✓Eden Health GLP-10/100✓Henry Meds0/100✓TrimRx0/100✓Enhance MD0/100✓MEDVi0/100✓Sesame Care0/100✓Strut Health0/100✓Ivim Health0/100✓bmiMD0/100✓Hone Health0/100✓Found0/100✓MyStart Health0/100✓AgelessRx0/100✓Direct Meds GLP-10/100
Disclaimer: This page tracks publicly available FDA enforcement actions. It is not exhaustive. Inclusion on the warned list means the FDA issued a formal letter, it does not necessarily mean the company is currently non-compliant. Companies may have resolved their violations. Always verify current status with the FDA Warning Letters database.