FDA warning letters to GLP-1 compounders and sellers, September 2025
Compounded semaglutide and tirzepatide · Announced 2025-09-09 · Last reviewed July 2026
With the tirzepatide shortage declared resolved in December 2024 and the semaglutide shortage in February 2025, the legal basis for routinely compounding "essentially a copy" of those drugs ended. In September 2025 the FDA announced a wave of warning letters to companies that continued compounding GLP-1 products or marketing unapproved GLP-1 drugs — citing violations of compounding rules, sourcing of semaglutide salt forms not permitted for compounding, and misleading marketing claims about equivalence to the approved products. Many recipients discontinued GLP-1 compounding; enforcement against non-compliant sellers has continued into 2026. Individual letters are published in the FDA's warning-letters database.
What's affected
- Compounding pharmacies and outsourcing facilities that continued GLP-1 compounding after the wind-down deadlines
- Online sellers marketing unapproved or research-use-only GLP-1 products to consumers
- Patients still receiving compounded GLP-1s from affected suppliers
What patients should do
- If you use compounded semaglutide or tirzepatide, ask the dispensing pharmacy whether it has received an FDA warning letter and what its current legal basis is
- Discuss transitioning to brand-name supply with your prescriber (NovoCare for Wegovy, LillyDirect for Zepbound)
- Never buy GLP-1 products marketed as 'research use only' — they are unapproved and their contents are unverified
- Report adverse events with compounded GLP-1s to FDA MedWatch