Overview
- Apothecary Pharma initiated a voluntary nationwide recall that began on September 24 and the FDA posted an Oct. 8 notice listing 22 vials of compounded tirzepatide (lots AP-202622–AP-202644, 18 mg/mL, 4 mL multidose) with beyond‑use dates from Oct. 7 to Nov. 26.
- The FDA classified the action as Class II, meaning the products may cause temporary or medically reversible health effects if contaminated, and the agency warned recipients to stop use and contact their pharmacist or prescriber.
- A December 2025 FDA inspection found serious sterile‑production failures at Apothecary Pharma, including workers touching sterile areas, not changing gloves, and equipment that was rusty or hard to clean.
- Because the company supplies some telehealth providers and the product is sold in multidose vials, more patients may be exposed; people who received injections should check vial labels and lot numbers and seek care for fever, redness, swelling, or worsening pain after injection.
- The recall comes as the FDA tightens scrutiny of compounded GLP‑1 drugs, has proposed removing certain GLP‑1s from outsourcing bulks lists, and won a September court decision that upheld parts of its enforcement approach.