FDA lists ongoing Apothecary Pharma recall of 22 tirzepatide multi-dose vials over lack of sterility assurance

FDA's Enforcement Report lists an ongoing voluntary recall by Apothecary Pharma LLC of Cary, North Carolina. Recall number D-0036-2027 sits under Event 99952: the firm initiated the recall on September 24, 2026, FDA classified it on October 8, and the record showed Ongoing status when checked October 19. National news coverage on October 19 describes the same record; it is not a recall initiated this week.

The listed product is tirzepatide injection, 18 mg/mL, in 4 mL sterile multi-dose vials, Rx only, NDC 85091-001-18. FDA gives the product quantity as 22 vials and the reason as lack of assurance of sterility. The code information lists lot codes beginning AP-202622, with beyond-use dates from October 7 to November 24, 2026. Those identifiers define the listed scope; the record does not cover every tirzepatide product or every product from the firm.

The recall is classified Class II, the category FDA uses when use of a violative product may cause temporary or medically reversible adverse health consequences and where serious harm is remote. The record shows nationwide distribution within the United States, firm-initiated voluntary action, and initial notification of consignees by letter. It states that no press release was issued for this recall.

FDA records also show prior enforcement history at the same firm: a warning letter issued December 1, 2025 (MARCS-CMS 717972) and a Form 483 issued May 15, 2025 whose listed observations include aseptic-process validation. A warning letter and a 483 describe FDA's inspection findings at the time; they are not, by themselves, a final agency determination, and the firm had the opportunity to respond or correct.

Compounded injectables of this kind are not FDA-approved products. Anyone checking a vial should match the exact product description and lot code against the FDA record and ask the dispensing pharmacy or treating clinician what recall-specific steps apply. This is a dated safety notice, not a provider endorsement, treatment recommendation or buying advice.