A Cary, North Carolina pharmacy is recalling 22 vials of compounded tirzepatide after federal regulators said the company cannot assure the products were made sterile, and the recall has already shipped nationwide. Apothecary Pharma LLC initiated the recall on September 24, and the Food and Drug Administration still lists it as ongoing, with notifications going out to customers by letter rather than a public announcement.
The recalled tirzepatide carries a strength of 18 mg/ml and comes packaged in 4 ml sterile multi-dose vials under NDC 85091-001-18, according to Daily Voice. The affected lots span AP-202622 through AP-202625 and AP-202627 through AP-202644, with beyond-use dates falling in October and November; lot AP-202626 is notably not included in the FDA listing. Patients can check whether their own vial is affected by matching its lot number and beyond-use date against the FDA enforcement report, and the full list of tirzepatide lots can be expanded by selecting “more” under code information on that listing, the outlet reports.
The recall also swept up a single vial of Apothecary NAD+ Injection, a 200 mg/ml product packaged in a 6 ml multi-dose vial under NDC 85091-011-06, carrying lot number AP-202647 and a beyond-use date of October 13. NAD+ is a separate product and not a GLP-1 medication, but it was pulled under the same sterility concerns. Anyone holding a vial that matches the recall listing should not use it and should instead contact their prescriber or dispensing pharmacy promptly to discuss replacement medication and handling instructions, per the same report.
What Triggered the Sterility Concern
The FDA’s enforcement listing states the recall reason as a lack of assurance of sterility, though it does not establish that contamination was actually found in every vial. Both the tirzepatide and NAD+ products carry a Class II designation, the agency’s middle tier of risk. The FDA defines a Class II recall as a situation where exposure to or use of a violative product may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote, according to Quartz.
The FDA’s enforcement listing states the recall reason as a lack of assurance of sterility, though it does not establish that contamination was actually found in every vial. Both the tirzepatide and NAD+ products carry a Class II designation, the agency’s middle tier of risk. The FDA defines a Class II recall as a situation where exposure to or use of a violative product may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote, according to Quartz. Quartz notes that the FDA did not issue a formal press release announcing the recall, leaving patients and journalists to track the development through updates posted to the FDA enforcement database and direct customer letters rather than a public FDA statement. That quiet rollout fits a pattern across the compounding industry, where sterility recalls are often disclosed only through regulatory filings.
A History of Federal Compliance Problems
This is not Apothecary Pharma’s first run-in with federal regulators. The FDA issued a formal Warning Letter to the company on December 1, 2025, citing serious sterile drug production deficiencies and a failure to comply with federal 503B outsourcing standards. During a four-day inspection of the Cary facility in May 2025, FDA inspectors documented exposed forehead and cheek skin during semaglutide production, according to the FDA.
Apothecary Pharma voluntarily halted sterile drug production on May 12, 2025, during that inspection, before notifying regulators of plans to resume sterile operations in August 2025, with company leadership at the time led by President and Chief Pharmacy Officer Priyanka Rana. Federal inspectors separately found that Apothecary Pharma’s compounded tirzepatide and semaglutide products omitted required container details, including active and inactive ingredient proportions, directions for use, and adverse-event contact information — violations cited under Section 503B, according to the National Alliance of State Pharmacy Associations.
Why Compounders Face More Scrutiny Now
Registered 503B outsourcing facilities like Apothecary Pharma are authorized to compound medication batches without individual patient prescriptions, but they must strictly comply with federal Current Good Manufacturing Practice rules, unlike traditional state-regulated pharmacies that fill individual prescriptions, per the MedShadow Foundation. The FDA removed tirzepatide from its national drug shortage list in October 2024, with that determination reaffirmed in December. Shortage-list removals affected rules for compounding versions of Mounjaro and Zepbound, but many compounders continued making versions after the removals, according to Quartz.
The agency went further this year, proposing a rule on April 30, 2026, to formally remove tirzepatide, semaglutide, and liraglutide from the 503B bulk drug substances list — an effort Hoodline previously reported would limit large-scale compounding and curb risky mass compounding. That proposed rule underwent a public comment period through late July 2026, according to the Health Law Alliance.
The MedShadow Foundation has discussed rising demand for GLP-1 drugs and related safety concerns.
What the FDA Wants Patients to Know
The FDA has previously cited manufacturing and other compliance deficiencies at Apothecary Pharma, and regulators continue to remind patients that compounded drugs are not FDA-approved. The agency advises using compounded drugs only when a patient’s medical needs cannot be met with an FDA-approved drug. For now, anyone holding an affected vial is urged to skip using it and reach out to their prescriber or pharmacy to sort out next steps.
