Federal regulators say a North Carolina compounding pharmacy, Apothecary Pharma, has pulled 23 vials of injectable drugs from the market over concerns they may not be sterile. The recall covers 22 vials of compounded tirzepatide - the active ingredient found in the brand-name drugs Mounjaro and Zepbound - plus one vial of an NAD+ injection, both distributed nationwide.
What triggered the recall
Apothecary Pharma, based in Cary, North Carolina, voluntarily initiated the recall on Sept. 24 after flagging a "lack of assurance of sterility" in its production process, according to an FDA notice cited by USA Today. On Oct. 10, the FDA escalated the action to a Class II recall, a designation indicating that use of the product could cause temporary or medically reversible health problems, though the probability of serious harm is considered low.
The affected product is an 18 mg/mL prescription tirzepatide injection sold in 4 mL multidose vials, listed under NDC number 85091-001-18. The recalled lots range from AP-202622 through AP-202625 and AP-202627 through AP-202644.
A pharmacy already under scrutiny
This is not the company's first run-in with federal regulators. The FDA had previously cited Apothecary Pharma for what the Los Angeles Times described as "serious deficiencies" in its manufacturing practices. On Dec. 1, 2025, the agency sent the pharmacy a warning letter outlining multiple violations, including what the FDA called "serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk."
Why compounded GLP-1 drugs carry added risk
Compounded medications are custom-formulated by pharmacies rather than manufactured and approved by the FDA as brand-name drugs. That means they do not undergo the same rigorous federal review for safety, effectiveness or manufacturing consistency as approved products like Mounjaro or Zepbound. Compounding has become more common amid high demand and supply shortages for GLP-1 medications, but it also shifts more responsibility for quality control onto individual pharmacies.
As of this report, neither the FDA nor Apothecary Pharma has issued public instructions for patients who may have received the affected vials. Anyone who purchased compounded tirzepatide or NAD+ injections from this pharmacy should check lot numbers against the recall notice and consult their prescriber or pharmacist with questions, rather than attempting to self-diagnose any potential reaction.