Apothecary Pharma recalls compounded tirzepatide and NAD+ vials over sterility concerns

A North Carolina outsourcing facility is pulling 22 vials of compounded tirzepatide injection from the market nationwide because it cannot assure the product is sterile, according to an FDA enforcement report. Tirzepatide is the active ingredient in Eli Lilly's Mounjaro, which is approved to treat type 2 diabetes and as Zepbound for management of weight and sleep apnea.

The voluntary, firm-initiated recall by Apothecary Pharma LLC of Cary, North Carolina, also covers a single vial of the company's NAD+ injection. The FDA designated both products as Class II recalls, a category the agency uses when exposure to a product may cause temporary or medically reversible health problems, or when the likelihood of serious harm is remote. The company notified customers by letter rather than through a news release, and the FDA lists the recall as ongoing.

Which tirzepatide lots are affected

The recall involves the Tirzepatide Injection 18 mg/mL, supplied in a 4 mL sterile multi-dose vial under NDC 85091-001-18. The 22 vials span 22 separate lots, numbered AP-202622 through AP-202625 and AP-202627 through AP-202644. Beyond-use dates on the affected lots run from early October through late November, meaning some vials could still be within their labeled use window.

The second product is Apothecary NAD+ Injection 200 mg/mL, a 6 mL sterile multi-dose vial (NDC 85091-011-06), from lot AP-202647. The enforcement report cites a lack of assurance of sterility for both products. That finding does not by itself mean contamination was detected, but it indicates the firm cannot confirm the drugs were produced under conditions that keep them sterile.

What the tirzepatide recall means for type 2 diabetes care

The FDA approved Mounjaro as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and the same molecule is marketed as Zepbound for weight management. Compounded tirzepatide carries neither approval, and the FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.

The patient population at stake is large. About 40.1 million people in the United States had diagnosed or undiagnosed diabetes in 2023, roughly 12% of the population, according to the Centers for Disease Control and Prevention.

The American Diabetes Association recommends against using non-FDA-approved compounded GLP-1 and dual GIP/GLP-1 receptor agonist products, citing uncertainty about their content, safety, quality and effectiveness, in a statement published in Diabetes Care.

Prior FDA warning letter cited aseptic practices

Apothecary Pharma is registered with the FDA as a 503B outsourcing facility, a category of compounder that can produce drugs without patient-specific prescriptions but must follow current good manufacturing practice requirements.

After inspecting the Cary facility in May 2025, the FDA issued a warning letter to the company citing insanitary conditions in sterile drug production, including personnel working with exposed skin in the facility's ISO 5 aseptic processing area. The enforcement report does not say whether the current recall is connected to those findings.

What the recall means for compounded GLP-1 oversight

The recall comes as federal regulators continue to narrow the path for compounded GLP-1 drugs. The FDA declared the national tirzepatide shortage resolved in October 2024, and compounders' grace periods for producing copies of the drug have since expired, according to an analysis by the law firm Orrick.

As of May 31, 2026, the FDA had received 990 adverse event reports involving compounded semaglutide and more than 730 involving compounded tirzepatide, figures the agency said are likely underreported.