Updated October 19, 2026, 5:26 p.m. ET
Compound GLP-1 injections made by a pharmacy previously warned by the Food and Drug Administration about putting “patients at risk” have been recalled nationwide.
Apothecary Pharma LLC first initiated a voluntary recall of tirzepatide injections, the active ingredient in Zepbound and Mounjaro, on September 24 for “lack of assurance of sterility,” according to an FDA advisory. The federal agency updated the recall on Oct. 10 to classify it as a “Class II” recall, meaning use of the drug could result in “temporary or medically reversible adverse health consequences.” However, the risk of serious harm is low.
The injections are compounded versions of GLP-1, meaning they were not branded or FDA approved and were custom formulated by a specialty pharmacy called a compounding pharmacy.
Sterility and hygiene issues have sparked controversy around pharmaceutical injection compounding in the past, such as in a 2012 case in which nearly 800 people fell ill and 64 died from an outbreak of fungal meningitis caused by unsanitary injections from the New England Compounding Center.
GLP-1 compounds have become a particular FDA priority since tirzepatide and semaglutide were removed from the official shortage drug list in late 2024 and early 2025, meaning the compounding pharmacies that filled the gap for millions of people had to stop mass-producing them. Many continued, prompting the agency to issue warnings and various legal challenges.
In December 2025, Apothecary Pharma received a warning letter from the FDA listing several violations, including “serious deficiencies in your production practices for drug products intended or intended to be sterile, which put patients at risk.”
USA TODAY contacted Apothecary Pharma and the FDA for comment on Oct. 19, but did not receive a response.
Which GLP-1 injections have been recalled?
A total of 22 vials of tirzepatide have been recalled nationwide.
- Apothecary Pharma Tirzepatide injection: Sterile multidose vial 18 mg/mL, 4 mL, Rx only, with the following lot codes and expiration dates (BUD):
- 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 01/11/2026
- Lot AP-202632, BUD 03/11/2026
- Lot AP-202633, BUD 07/11/2026
- Lot AP-202634, BUD 08/11/2026
- Lot AP-202635, BUD 11/16/2026
- Lot AP-202636, BUD 11/17/2026
- Lot AP-202637, BUD 11/18/2026
- Lot AP-202638, BUD 11/19/2026
- Lot AP-202639, BUD 11/20/2026
- Lot AP-202640, BUD 11/21/2026
- Lot AP-202641, BUD 11/22/2026
- Lot AP-202642, BUD 11/24/2026
- Lot AP-202643, BUD 11/25/2026
- Lot AP-202644, BUD 11/26/2026
What to do with recalled GLP-1 injections
The FDA and Apothecary have not issued a public statement on what to do with the affected vials; Meanwhile, online customers have reported requests from their prescribers to return or dispose of them.
If you have an affected lot, do not use it. Contact your doctor to find out what to do with the recalled medications.
What are compounding pharmacies? Are they safe?
Compounding pharmacies, or specialty pharmacies that create personalized versions of drugs from raw materials, have gained renewed interest in recent years thanks to the rise of GLP-1 and the peptide industry.
Unlike a commercial pharmacy, which sells mass-produced medications, a compounding pharmacy can develop specific medications to meet a patient’s needs, including adjusting the dose or removing allergens like dyes. Compounding pharmacies are often used for pediatric and veterinary cases where a medication requires a different format, such as a low concentration liquid for a small animal.
These pharmacies are also sometimes used during drug shortages, as the FDA grants them temporary authorization to produce a bulk drug to fill the gap.
This was the case in 2022, when the FDA gave compounders the green light to begin producing their own versions of GLP-1 drugs in case of shortages. Tirzepatide and semaglutide were removed from the official shortage drug list in late 2024 and early 2025, but compounding pharmacies continued to produce their own versions and then sell them to millions of people, including through telehealth platforms like His/Hers.
Compounding pharmacies must use FDA-approved ingredients, but the formulations themselves are not evaluated for purity, safety, or effectiveness, including mass-produced drugs. Compounding pharmacies are also not routinely regulated by the FDA, which has led to sanitation and contamination issues, such as the 2021 New England Compounding Center case or the 2023 FDA reports on compounders using unapproved forms of salty ingredients in their formulations.
These factors have become increasingly controversial, with pharmaceutical giants like Eli Lilly and Novo Nordisk suing compounders to stop or limit the practice.
To see if your compounding pharmacy is reputable, visit the Alliance for Pharmacy Compounding website and talk to your doctor.
Gn bussni
