Compounded Tirzepatide Recall: How to Read It
A nationwide recall of compounded tirzepatide made the rounds this week. Here is what the FDA record actually says: who recalled what, how much, why, and how to check a vial you already have.
Reading an FDA Recall Entry
This is the reason code on the recall. It means the firm could not show that its process reliably produces a sterile product. The FDA entry for D-0036-2027 lists the reason only; it does not report that an organism was found in any vial or that anyone was harmed.
FDA defines Class II as a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Class I is reserved for a reasonable probability of serious harm or death.
The recall lists 22 lot numbers, AP-202622 through AP-202644 (AP-202626 is not listed), each with a beyond-use date (BUD) between 07-Oct-2026 and 26-Nov-2026. Product: Tirzepatide Injection 18 mg/mL, 4 mL multi-dose vial, NDC 85091-001-18.
The recalling firm is Apothecary Pharma LLC, a compounding pharmacy in Cary, NC. Compounded tirzepatide is not an FDA-approved product, and Eli Lilly's branded pens and vials are not part of this recall entry.
What the Data Shows
How to Check Your Vial Against a Recall
Key Takeaways
- Apothecary Pharma LLC (Cary, NC) voluntarily recalled 22 vials of compounded Tirzepatide Injection 18 mg/mL across 22 lots; the recall began 2026-09-24 and FDA classified it Class II on 2026-10-08 (D-0036-2027). Distribution was nationwide.
- The same FDA report week also lists Carolina Infusion compounded tirzepatide and tirzepatide/cyanocobalamin syringes, with the sterility concern tied to formulation using bacteriostatic water and to processing equipment.
- Sterility lapses in compounding have caused real outbreaks: 11 outbreaks with 207 infected patients and 17 deaths in 2000-2012 before the 2012 fungal meningitis outbreak (PMID 23867487), which itself involved 751 patients and 64 deaths (PMID 25443512).
- A 2025 secret-shopper study of compounded GLP-1 suppliers found 4 of 21 supplying facilities were not licensed for sterile compounding (PMID 42467450).
- In a 2025 survey of 33 compounded semaglutide/tirzepatide products with non-standard formulations, only 18% reported information about beyond-use date and preferred storage conditions (PMID 41689811).
- Lilly-authored lab testing reported a widespread impurity in compounded tirzepatide/B12 combinations, formed by a reaction between tirzepatide and certain B12 analogs (PMID 42010938).
- Whether any recalled Apothecary or Carolina Infusion vial was actually contaminated: the FDA entries give a reason code, not test results.
- Whether any patient was harmed by these lots: no injury reports appear in the enforcement records.
- How many patients received the recalled product.
- The clinical effect, if any, of the tirzepatide/B12 impurity; the authors state it is unknown, and the testing was done by the brand manufacturer.
- Whether the openFDA product search captures every tirzepatide recall; it is a free-text search and can miss entries.
Frequently Asked Questions
Is Mounjaro or Zepbound part of the compounded tirzepatide recall?
No. The FDA Enforcement Report entry (D-0036-2027) names Apothecary Pharma LLC, a compounding pharmacy in Cary, NC, and a compounded Tirzepatide Injection 18 mg/mL multi-dose vial, NDC 85091-001-18. Eli Lilly's FDA-approved Mounjaro and Zepbound products are not listed in this recall.
What does 'lack of assurance of sterility' mean on a recall?
It means the firm could not demonstrate that its manufacturing process reliably produces a sterile injectable. It is a process finding. The FDA entry for this recall lists only that reason; it does not state that contamination was found in a vial or that a patient was harmed.
How do I check if my compounded tirzepatide vial is recalled?
Compare the pharmacy name, NDC, lot number and beyond-use date on your vial with the code info in the FDA Enforcement Report. The Apothecary Pharma recall lists lots AP-202622 through AP-202644 (excluding AP-202626). If yours matches, contact the dispensing pharmacy and your prescriber, and report any reaction to FDA MedWatch.
What is a Class II drug recall?
FDA uses Class II when use of the product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. Class I is the most serious category, used when there is a reasonable probability of serious harm or death.
How common are compounded tirzepatide recalls?
An openFDA search for tirzepatide products returned 27 recall entries from 2023 to October 2026, across 8 firms. 18 of those entries cite lack of assurance of sterility. One 2024 entry was Class I: a vial labeled as tirzepatide that contained testosterone cypionate.
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Educational purposes only. Not medical advice. Recall facts are taken from FDA Enforcement Report entries (openFDA, data updated 2026-10-14) and can change; check the FDA database for the current status.
If you have a vial that may be affected, talk to your dispensing pharmacy and prescriber.