Apothecary Pharma Recalls Compounded Tirzepatide GLP-1 Injections Nationwide Over Sterility Concerns
Apothecary Pharma LLC has voluntarily recalled 22 vials of compounded tirzepatide injection (18 mg/mL in 4 mL multi-dose vials) nationwide after the FDA determined the products lack assurance of sterility, posing a risk of serious infection if the vials are contaminated. The recall was initiated September 24, 2026, and classified as Class II by the FDA on October 8, 2026. Important: this recall does not affect brand-name Mounjaro or Zepbound — only compounded tirzepatide prepared by Apothecary Pharma is recalled. No adverse events have been reported.
What's Being Recalled?
The recall covers Apothecary Pharma compounded tirzepatide injection, 18 mg/mL, in 4 mL sterile multidose vials, lots AP-202622 through AP-202644, with beyond-use dates ranging from October 7 through November 26, 2026. One additional vial — Apothecary NAD+ injection, 200 mg/mL, lot AP-202647 — is also recalled under the same Class II classification for the same reason. The complete lot number list with specific beyond-use dates is available in the FDA enforcement report at fda.gov. No other products or lot numbers from any other manufacturer are included.
Why Was This Product Recalled?
The FDA determined the recalled vials lack assurance of sterility — meaning the compounding pharmacy cannot sufficiently demonstrate the injectable medication is free from microbial contamination. Injectable medications that are not sterile can introduce bacteria, fungus, or other pathogens directly into the bloodstream or tissue, causing serious infections including sepsis. The FDA had already sent Apothecary Pharma a warning letter in December 2025 citing "serious deficiencies" in its sterile drug manufacturing practices that "put patients at risk." The recall comes amid broader FDA scrutiny of compounding pharmacies producing GLP-1 medications after both tirzepatide and semaglutide were removed from the federal drug shortage list in late 2024 and early 2025.
What Should You Do?
Do not use any Apothecary Pharma tirzepatide injection vial with lot numbers AP-202622 through AP-202644. Contact your prescribing doctor or healthcare provider immediately before using any recalled vials — do not stop your GLP-1 treatment without medical guidance, as your provider can help arrange a replacement from an unaffected source. If you have already injected from a recalled vial and experience fever, chills, redness or swelling at the injection site, or any signs of infection, seek medical care immediately. Patients taking brand-name Mounjaro or Zepbound are not affected by this recall.
