Nationwide Recall of Compounded GLP-1 Injections
Apothecary Pharma LLC has initiated a nationwide recall of compounded GLP-1 injections, specifically tirzepatide, due to concerns over sterility. The recall was first voluntarily announced on September 24, following an FDA notice highlighting the lack of sterility assurance. On October 10, the FDA classified the recall as ‘Class II,’ indicating potential temporary or reversible health consequences, with a small risk of severe harm.
These injections are compounded versions, meaning they are custom-made by a compounding pharmacy and are neither name-brand nor FDA-approved. The FDA has targeted these compounded GLP-1s after removing tirzepatide and semaglutide from its drug shortage list. This removal should have halted mass production by compounding pharmacies, yet many of them continue, prompting warnings and legal challenges.
“In December 2025, the FDA issued a warning letter to Apothecary Pharma, citing serious deficiencies in their sterile drug production practices, which posed risks to patients,” the agency stated.
Compounded GLP-1s have been scrutinized, partly due to past controversies, like the 2012 outbreak of fungal meningitis, causing illness in nearly 800 people and 64 fatalities due to unsanitary injections from New England Compounding Center.
Recalled Tirzepatide Injections
The recall involves 22 vials of tirzepatide with the following lot codes and beyond-use dates:
- Lot AP-202622, BUD 07-Oct-2026
- Lot AP-202623, BUD 08-Oct-2026
- Lot AP-202624, BUD 19-Oct-2026
- Lot AP-202625, BUD 10/20/2026
- Lot AP-202627, BUD 10/26/2026
- Lot AP-202628, BUD 10/27/2026
- Lot AP-202629, BUD 10/28/2026
- Lot AP-202630, BUD 10/31/2026
- Lot AP-202631, BUD 11/01/2026
- …
With no official statement on handling recalled vials, customers reported through prescribers that they are advised not to use them and to seek further instructions.
Understanding Compounding Pharmacies
Compounding pharmacies create customized drugs from raw ingredients. Unlike commercial pharmacies, they tailor medications, adjusting doses or excluding allergens like dyes. They’re popular in pediatric and veterinary care, for instance, when a lower-concentration liquid is needed.
During drug shortages, compounding pharmacies receive temporary FDA approval to produce drugs in bulk. This occurred in 2022 when compounders began making GLP-1 medications during a shortage.
Compounding pharmacies utilize FDA-approved ingredients, but their formulations aren’t routinely evaluated for purity, safety, or effectiveness. They aren’t subject to regular FDA regulations, leading to some sanitation and contamination issues.
For reassurance on your pharmacy’s credibility, consult the Alliance for Pharmacy Compounding website and discuss with your doctor.