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 found selling illegal compounded semaglutide, using improper marketing claims, or 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 |
Verified GLP-1 Providers
These providers have been independently verified for pharmacy licensing, FDA compliance, and operational legitimacy. 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.