UNITED STATES: The US Food and Drug Administration (FDA) has classified a recall involving 22 vials of compounded tirzepatide manufactured by Apothecary Pharma over concerns that the products may not be sterile. The recall also includes one vial of NAD+ injection from the same company, bringing the total to 23 vials.
The recall affects specific compounded injectable products distributed in the United States. The brand-name medications Mounjaro and Zepbound, which contain tirzepatide, are not included in this recall. The FDA classified the action as Class II on October 8, 2026, indicating that exposure to the affected products may cause temporary or medically reversible health consequences.
Which products are affected?
The recall covers compounded tirzepatide injection supplied by Apothecary Pharma in 18 mg/mL strength, packaged in 4 mL multidose vials. The affected products carry the National Drug Code (NDC) 85091-001-18.
The company is also recalling one vial of compounded NAD+ injection, supplied in a 200 mg/mL strength in a 6 mL multidose vial. The product carries NDC 85091-011-06.
Both recalls cite a lack of assurance of sterility, meaning the manufacturer cannot adequately guarantee that the affected injectable products are free from microbial contamination.
Tirzepatide is the active ingredient in the FDA-approved medicines Mounjaro, used to treat type 2 diabetes, and Zepbound, approved for chronic weight management and certain other indications. However, the recall specifically concerns compounded products supplied by Apothecary Pharma, not these brand-name medicines.
Recall follows earlier FDA warning
The recall follows an FDA warning letter issued to Apothecary Pharma in December 2025. The agency had identified serious deficiencies in the company’s practices for producing sterile drug products.
The earlier warning raised concerns about manufacturing procedures intended to protect injectable medicines from contamination. The FDA has not established that the deficiencies identified in the earlier inspection caused the current sterility concern, but the recall has renewed attention to the importance of maintaining appropriate standards in sterile drug production.
The company initiated the voluntary recall on September 24, 2026, and notified recipients by letter. The FDA subsequently classified the recall as Class II on October 8. The recall remained ongoing in the latest available reports.
Patients advised to check vial labels
Patients who use compounded tirzepatide or NAD+ injections should check their vial labels and pharmacy records to determine whether their products are affected. Relevant identifiers include the product name, strength, NDC and lot number.
The recalled tirzepatide vials carry NDC 85091-001-18, while the affected NAD+ injection carries NDC 85091-011-06. Patients should compare their products with the complete affected-lot lists in the official recall notice.
Anyone who identifies a potentially affected product should stop using it and contact their dispensing pharmacy or healthcare provider for instructions on replacement, disposal and alternative treatment. Patients should not change their prescribed diabetes or weight-management treatment without consulting their healthcare professional.
People who have already used an affected injection and develop symptoms such as fever, redness, swelling or worsening pain at the injection site should seek medical advice promptly.
Why sterility matters for injectable medicines
Injectable medicines must be manufactured and handled under appropriate sterile conditions because contamination can introduce microorganisms into the body. Depending on the contaminant and the patient’s circumstances, exposure may lead to infection or other health complications.
Compounded medicines are prepared by pharmacies or other authorised facilities for particular medical needs, but they are not the same as FDA-approved finished drug products. Their quality depends on appropriate preparation, handling and quality-control procedures.
The recall highlights the importance of verifying product details and following official safety instructions when a medicine is recalled. Patients who have concerns about compounded injections should discuss them with their healthcare providers and obtain information directly from the dispensing pharmacy.
The FDA’s Class II classification indicates that serious adverse health consequences are unlikely, although temporary or medically reversible effects remain possible. The latest available reports did not identify confirmed illnesses or injuries linked to this particular recall.