Nationwide Recall Issued for Compounded GLP-1 and NAD+ Injections Over Sterility Concerns
A voluntary nationwide recall has been initiated for 23 vials of injectable medications, encompassing a widely used compounded weight-loss drug, over concerns regarding potential lack of sterility. North Carolina-based compounding facility Apothecary Pharma issued the recall covering 22 distinct vials of compounded tirzepatide alongside a single vial of NAD+ injection, federal records show.
The Food and Drug Administration classified the action as a Class II recall on October 8. This classification indicates that the affected products could potentially cause temporary or medically reversible adverse health consequences, while the likelihood of serious adverse effects remains low. The regulatory agency confirmed that the recall effort is currently ongoing.
Tirzepatide serves as the active pharmaceutical ingredient found in major brand-name treatments manufactured by Eli Lilly, specifically the weight-loss medication Zepbound and the type 2 diabetes treatment Mounjaro. However, federal officials emphasized that the recalled merchandise consists strictly of compounded formulations rather than the FDA-approved brand-name pharmaceutical products.
The recall impacts prescription-grade injection lots distributed across the United States. Patients and medical providers who have acquired these items are advised to closely inspect their vial labels against specific tracking data provided by regulators.
The affected tirzepatide injections are supplied at a strength of 18 milligrams per milliliter within 4-milliliter multidose vials carrying the National Drug Code 85091-001-18. The recalled lots include batch numbers AP-202622, AP-202623, AP-202624, AP-202625, and a continuous sequence from AP-202627 through AP-202644. These batches carry beyond-use dates ranging from October 7 to November 26, 2026.
Additionally, one lot of NAD+ injection is included in the recall. This product has a strength of 200 milligrams per milliliter packaged in 6-milliliter multidose vials under the National Drug Code 85091-011-06. Identified under lot number AP-202647, the product features a beyond-use date of October 13, 2026.
Apothecary Pharma commenced the recall on September 24 by dispatching notification letters to recipients. The nationwide action follows regulatory scrutiny stemming from a December warning letter issued by the FDA regarding significant deficiencies observed in the facility’s sterile drug manufacturing practices. While federal regulators noted that those manufacturing shortcomings presented potential hazards to patients, the agency has not formally established a direct causal link between those historical deficiencies and the current sterility concerns.
Compounded medications are formulated by specialized pharmacies to fulfill customized prescriptions tailored to individual patient requirements. Unlike commercially manufactured drugs that receive direct federal approval, compounded alternatives do not undergo the rigorous pre-market evaluations for safety, efficacy, and manufacturing quality that standard commercial pharmaceuticals must satisfy.
Health authorities advise anyone in possession of the recalled items to discontinue use immediately and consult a pharmacist or primary healthcare provider for guidance. Individuals who have administered an affected injection and subsequently developed symptoms such as fever, localized redness, swelling, or escalating pain are instructed to seek medical evaluation promptly. As of the current reporting, the FDA has not documented any adverse illnesses or injuries directly associated with the recalled batches.
