Finance Daily
Tuesday, 20 October 2026

GLP-1 injections recalled nationwide. See affected products

2026-10-19 · 3 min read

Apothecary Pharma LLC has issued a nationwide recall of compounded GLP-1 injections, following a prior warning from the Food and Drug Administration (FDA) that highlighted potential risks to patients. The recall, which affects tirzepatide injections—the active ingredient found in the branded medications Zepbound and Mounjaro—was first announced on September 24, citing concerns over a "lack of assurance of sterility." On October 10, the FDA upgraded the recall to a "Class II" designation, indicating that while the medication could lead to "temporary or medically reversible adverse health consequences," the likelihood of serious harm remains low.

The recalled injections are compounded formulations, meaning they are not FDA-approved or commercially branded but instead created by specialized pharmacies known as compounding pharmacies. Issues surrounding the sterility of compounded injections have previously raised alarms, notably in a 2012 outbreak of fungal meningitis linked to unsanitary practices at the New England Compounding Center, which resulted in nearly 800 illnesses and 64 deaths.

Since the removal of tirzepatide and semaglutide from the official drug shortage list in late 2024 and early 2025, compounded GLP-1s have come under increased scrutiny from the FDA. The agency has observed that many compounding pharmacies continued to produce these medications despite the return of the branded versions to the market, leading to warnings and legal actions against these pharmacies.

In December 2025, Apothecary Pharma received a warning letter from the FDA citing multiple violations, including "serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk." As of October 19, attempts by USA TODAY to obtain comments from Apothecary Pharma and the FDA have gone unanswered.

The recall includes 22 vials of tirzepatide, specifically the Apothecary Pharma Tirzepatide Injection at a concentration of 18mg/mL in 4 mL sterile multi-dose vials. The affected lot codes and their corresponding beyond-use dates (BUD) are as follows:

  • 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 20-Oct-2026
  • Lot AP-202627, BUD 26-Oct-2026
  • Lot AP-202628, BUD 27-Oct-2026
  • Lot AP-202629, BUD 28-Oct-2026
  • Lot AP-202630, BUD 31-Oct-2026
  • Lot AP-202631, BUD 01-Nov-2026
  • Lot AP-202632, BUD 03-Nov-2026
  • Lot AP-202633, BUD 07-Nov-2026
  • Lot AP-202634, BUD 08-Nov-2026
  • Lot AP-202635, BUD 16-Nov-2026
  • Lot AP-202636, BUD 17-Nov-2026
  • Lot AP-202637, BUD 18-Nov-2026
  • Lot AP-202638, BUD 19-Nov-2026
  • Lot AP-202639, BUD 20-Nov-2026
  • Lot AP-202640, BUD 21-Nov-2026
  • Lot AP-202641, BUD 22-Nov-2026
  • Lot AP-202642, BUD 24-Nov-2026
  • Lot AP-202643, BUD 25-Nov-2026
  • Lot AP-202644, BUD 26-Nov-2026

Currently, neither the FDA nor Apothecary Pharma has provided public guidance regarding the disposal of the recalled vials. Customers have reported that their prescribers have requested the return or disposal of these products. Individuals who possess any of the affected lots are advised not to use them and to reach out to their healthcare provider for further instructions.

Compounding pharmacies, which create customized drug formulations from raw ingredients, have gained attention in light of the growing demand for GLP-1 medications. They differ from commercial pharmacies by providing tailored medications, such as adjusting dosages or eliminating allergens. These pharmacies often serve pediatric and veterinary patients who may require different medication forms.

During periods of drug shortages, the FDA may grant temporary approvals for compounding pharmacies to produce medications in bulk. This occurred in 2022, allowing them to make GLP-1 medications amid shortages. However, with the return of tirzepatide and semaglutide to the market, many compounding pharmacies have continued to manufacture and sell these alternatives, often through telehealth services.

While compounding pharmacies are required to use FDA-approved ingredients, the formulations themselves are not subject to the same level of scrutiny for safety, purity, or effectiveness as mass-produced drugs. Additionally, these pharmacies are not consistently regulated by the FDA, which has led to sanitation issues and contamination incidents. Concerns over these practices have prompted legal action from major pharmaceutical companies, including Eli Lilly and Novo Nordisk, aimed at restricting the activities of compounding pharmacies.

For consumers seeking to verify the reliability of a compounding pharmacy, resources such as the Alliance for Pharmacy Compounding website can provide guidance, and consulting with healthcare professionals is recommended.