FDA Recalls 23 Vials of Injectables Due to Sterility Concerns

Apothecary Pharma is pulling 23 vials of injectable drugs from the market nationwide because sterility cannot be assured, according to the Food and Drug Administration. This action follows a warning letter sent back in December 2025 that highlighted serious problems with how this North Carolina company makes sterile medicines. The agency stated these issues put patients at risk but has not yet linked those specific findings to the current recall.

The voluntary pull includes 22 vials of compounded tirzepatide and one vial containing an NAD+ injection. Tirzepatide carries the same active ingredient found in Eli Lilly's Mounjaro and Zepbound, while the FDA labeled this event as a Class II recall on Oct. 8. That classification means serious health consequences are considered unlikely. The specific tirzepatide product is an 18 mg/mL prescription injection inside a 4 mL multidose vial with NDC number 85091-001-18.

Recalled lots for the weight-loss drug range from AP-202622 through AP-202625 and AP-202627 through AP-202644. These items have beyond-use dates spanning from Oct. 7 through Nov. 26, 2026. The NAD+ injection is a different 200 mg/mL prescription product stored in a 6 mL multidose vial with NDC 85091-011-06. Only lot AP-202647 is affected here, and it must be used by Oct. 13, 2026.

Apothecary Pharma started the recall process on Sept. 24 and sent letters to recipients to inform them. The situation remains ongoing as authorities continue their review. Anyone holding these vials or seeing pharmacy records should stop using the products immediately and contact their pharmacist or prescriber for guidance. If you experience fever, redness, swelling, or worsening pain after receiving an affected injection, seek medical advice right away.

The FDA notice did not identify any reported illnesses or injuries linked to this specific recall at this time. Consumers are urged to double-check their supplies against the lot numbers listed above. This situation highlights why strict production standards matter when it comes to drugs injected directly into the body. The company faces scrutiny after earlier deficiencies were found in its North Carolina facility.