FDA warning letters to 30+ compounding pharmacies, July 2025
Compounded semaglutide and tirzepatide · Announced 2025-07-15 · Last reviewed May 2026
Following the FDA's declaration that semaglutide and tirzepatide shortages were resolved (February and October 2025 respectively), the FDA issued warning letters to more than 30 compounding pharmacies that continued offering compounded versions of these molecules. The warnings cited failure to comply with 503A bulk-compounding rules, sourcing semaglutide salt forms from non-registered manufacturers, and making misleading claims about therapeutic equivalence to brand-name products. Many recipient pharmacies discontinued GLP-1 compounding within the 30-day response window; a small number challenged the FDA position legally and continue offering compounded GLP-1s in restricted circumstances.
What's affected
- 30+ compounding pharmacies receiving FDA warning letters between July 2025 and January 2026
- Telehealth platforms which previously sourced from these pharmacies (many transitioned to brand-name supply)
- Patients who switched to compounded GLP-1s during the shortage period
What patients should do
- If currently using compounded semaglutide or tirzepatide, confirm with your prescriber whether your pharmacy received a warning letter
- Request transition to brand-name supply (NovoCare $499/mo Wegovy; LillyDirect $349-549/mo Zepbound vials)
- Verify your compounding pharmacy's 503A or 503B status and FDA registration
- Report adverse events with compounded GLP-1s to FDA MedWatch