A 503B Compounder Recalls Tirzepatide Vials Over Sterility Assurance

Apothecary Pharma LLC, a compounding company in Cary, North Carolina, has voluntarily recalled 22 vials of compounded tirzepatide injection distributed nationwide, according to an FDA enforcement report described by Managed Healthcare Executive. The stated reason is a "lack of assurance of sterility." Tirzepatide is the active ingredient in Eli Lilly's Mounjaro and Zepbound; the compounded product carries neither approval.

The recall covers Tirzepatide Injection 18 mg/mL in a 4 mL multi-dose vial (NDC 85091-001-18). Managed Healthcare Executive reported that the 22 vials span 22 separate lots, numbered AP-202622 through AP-202625 and AP-202627 through AP-202644, with beyond-use dates running from early October through late November. One vial of the company's NAD+ injection (lot AP-202647) is also included.

BioPharma Dive reported that the company notified the FDA in September, and that the agency classified the recall as Class II, a category for products that may cause temporary or medically reversible health problems or where serious harm is considered remote. According to Managed Healthcare Executive, customers were notified by letter rather than through a news release, and the recall is listed as ongoing.

The phrase does not by itself mean contamination was found. As Managed Healthcare Executive noted, it indicates the firm cannot confirm the drug was made under conditions that keep it sterile, which matters for any injectable product.

Apothecary Pharma is registered as a 503B outsourcing facility, which may compound without patient-specific prescriptions but must follow current good manufacturing practice rules. After a May 2025 inspection, the FDA issued the company a warning letter citing insanitary conditions in sterile production, Managed Healthcare Executive reported. The enforcement report does not say whether the current recall is connected to those findings.

The recall lands as Lilly and Novo Nordisk press legal action against compounded GLP-1 sellers, BioPharma Dive noted, even though the drug shortages that drove early compounding have ended.

Anyone using compounded tirzepatide can check the vial label for NDC 85091-001-18 and the listed lot numbers, and should contact the dispensing pharmacy or prescriber if a vial matches rather than keep using it. More broadly, the FDA does not review compounded drugs for safety or quality before sale, so the source of a compounded injection is worth asking about.