Compounded 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 Sept. 24 for “lack of assurance of sterility,” according to an FDA notice. The federal agency updated the recall on Oct. 10 to classify it as a “Class II” recall, meaning using the medication could cause “temporary or medically reversible adverse health consequences.” However, the risk of serious harm is small.
The injections are compounded versions of the GLP-1, meaning they were not name-brand or FDA-approved and were custom formulated by a specialized pharmacy called a compounding pharmacy.
Sterility and sanitation issues have stirred controversy around compounding pharmacy injections in the past, such as a 2012 case in which nearly 800 people became ill and 64 died from a fungal meningitis outbreak caused by unsanitary injections from the New England Compounding Center.
Compounded GLP-1s have become a special focus of the FDA since the removal of tirzepatide and semaglutide from the official drug shortage list in late 2024 and early 2025, meaning compounding pharmacies that filled the gap for millions were expected to stop producing them en masse. Many have continued, prompting the agency to issue warnings and various legal challenges.
In December 2025, Apothecary Pharma received an FDA warning letter listing several violations, including “serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.”
USA TODAY contacted Apothecary Pharma and the FDA for comment on Oct. 19, but has not received a response.
Which Compounded GLP-1 Injections Were Recalled?
A total of 22 vials of tirzepatide were recalled nationwide.
- Apothecary Pharma Tirzepatide Injection: 18mg/mL, 4 mL sterile multi-dose vial, Rx only, with the following lot codes and beyond-use 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 11/01/2026
- Lot AP-202632, BUD 11/03/2026
- Lot AP-202633, BUD 11/07/2026
- Lot AP-202634, BUD 11/08/2026
- 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 affected vials; meanwhile, customers online have reported requests through their prescribers to return or dispose of them.
If you have an affected lot, do not use it. Contact your prescriber for instructions on what to do with recalled medication.
What Are Compounding Pharmacies? Are They Safe?
Compounding pharmacies, or special pharmacies that create customized versions of drugs from raw ingredients, have sparked renewed interest in recent years thanks to the surge of GLP-1s and the peptides industry.
Unlike a commercial pharmacy, which sells mass-produced drugs, a compounding pharmacy can develop specific medications to meet a patient’s needs, including by adjusting the dose or removing allergens like dyes. Compounding pharmacies are often used for pediatric and veterinary cases where a medicine needs a different format, such as a lower-concentration liquid for a small animal.
These pharmacies are also sometimes used during drug shortages, as the FDA grants temporary approval for them to produce a drug in bulk to fill the void.
This was the case in 2022 when the FDA gave compounders the go-ahead to begin producing their own versions of GLP-1 medications amid a shortage. Tirzepatide and semaglutide were removed from the official drug shortage list in late 2024 and early 2025, but compounding pharmacies have continued to produce their own versions and then sell them to millions, especially through telehealth platforms like His/Hers.
Compounding pharmacies must use FDA-approved ingredients, but the actual formulations themselves aren’t evaluated for purity, safety or effectiveness, including mass-produced medications. Compounding pharmacies also aren’t routinely FDA-regulated, which has led to sanitation and contamination issues, such as the 2021 New England Compounding Center case or 2023 FDA reports of compounders using unapproved salt forms of 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 check whether your compounding pharmacy is reputable, visit the Alliance for Pharmacy Compounding website and speak with your doctor.
Reporting by Mary Walrath-Holdridge, USA TODAY / USA TODAY
USA TODAY Network via Reuters Connect
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