Compounded GLP-1 injections made by Apothecary Pharma LLC, previously warned by the Food and Drug Administration (FDA) for safety issues, have been recalled across the nation. The pharmacy initially began a voluntary recall of tirzepatide injections on September 24 due to ‘lack of assurance of sterility,’ as noted in an FDA notice. On October 10, the recall was updated to a ‘Class II’ recall, indicating that using the medication could result in ‘temporary or medically reversible adverse health consequences.’ The likelihood of serious harm remains minimal.
Details of the Recall
The recalled injections are compounded versions of GLP-1, not approved by the FDA, custom-formulated by a specialized pharmacy. Concerns over sterility and sanitation have stirred previous controversies, such as the 2012 fungal meningitis outbreak tied to unsanitary injections from the New England Compounding Center, which led to nearly 800 illnesses and 64 deaths.
The FDA has increasingly focused on compounded GLP-1 medications, particularly after tirzepatide and semaglutide were removed from the drug shortage list in late 2024 and early 2025. Compounding pharmacies were then expected to halt mass production, yet many continued, prompting warnings and legal challenges from the agency.
In December 2025, Apothecary Pharma received an FDA warning citing ‘serious deficiencies in practices for producing drug products expected to be sterile,’ putting patients at risk. Despite contact attempts by USA TODAY on October 19, neither Apothecary Pharma nor the FDA has responded for comments.
Compounded GLP-1 Injections Recalled
In total, 22 vials of tirzepatide have been recalled nationwide:
- 18mg/mL, 4 mL sterile multi-dose vial, Rx only, with specific 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
- 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
Recommended Actions for Affected Users
The FDA and Apothecary have not provided public guidance on handling affected vials. However, reports indicate that customers have been advised to consult their prescribers for further instructions.
If you possess any affected lot, discontinue usage immediately. Contact your prescriber for recommendations on disposing of or returning the medication.
Understanding Compounding Pharmacies and Their Safety
Compounding pharmacies, which create customized drug versions from raw ingredients, have gained attention due to increased demand for GLP-1s and peptides. These pharmacies cater to specific patient needs by adjusting doses or removing allergens. They are also utilized during drug shortages, following FDA temporary approval for bulk production.
In 2022, the FDA allowed compounders to produce GLP-1 medications during a shortage. Despite tirzepatide and semaglutide removal from the shortage list in late 2024 and early 2025, production continues, particularly via telehealth platforms. While compounding pharmacies must use FDA-approved components, their formulations aren’t routinely assessed for quality. Their operations have faced scrutiny due to sanitation issues and reports of using unapproved ingredient forms.
To verify the credibility of a compounding pharmacy, visit the Alliance for Pharmacy Compounding site or consult your healthcare provider.
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