Compounded Tirzepatide Recall: Apothecary Pharma Lots and Patient Steps
Medically reviewed by Dr. Michael Teplitsky, MD Last reviewed 2026-10-20
How to check your vial label, understand sterility notices, and contact your provider
Only specific vials from Apothecary Pharma of Cary, North Carolina, with lot numbers AP-202622 through AP-202644 are named in this compounded tirzepatide recall. Press reports put the total at 22 vials. The product is tirzepatide 18 mg/mL in 4 mL multi-dose vials. The reason is a lack of sterility assurance, and FDA classed it Class II. Check the exact lot list in the FDA Enforcement Report before drawing a conclusion. USA Today advised patients who find one of these lot numbers on their packaging to stop using the vial and contact their prescriber or dispensing pharmacy.
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The recall applies to compounded tirzepatide injection prepared by Apothecary Pharma, located in Cary, North Carolina. According to reporting from Quartz: Apothecary Pharma recalls tirzepatide injections over sterility and Becker's Hospital Review: compounded GLP-1 injections recalled nationwide, the action covers 22 vials. Each is 18 mg/mL tirzepatide in a 4 mL multi-dose vial.
The affected lot numbers run in a sequence from AP-202622 through AP-202644, bearing beyond-use dates between October 7, 2026, and November 26, 2026. Not every number in that range is necessarily recalled. Quartz also reported that the same regulatory action includes one vial of NAD+ injection from Apothecary Pharma. Its lot is AP-202647. Same class, same reason.
How to Find the Lot Number
Read the label on the vial. It shows the lot number and the beyond-use date. If the vial label is difficult to read, inspect the outer carton or pharmacy label.
If the original packaging is lost, damaged, or unreadable, ask the dispensing pharmacy for the lot.
The label names the dispensing pharmacy.
What Lack of Sterility Assurance and Class II Mean
A lack of sterility assurance indicates that the compounding pharmacy could not demonstrate that the medication was made and tested to be sterile. This regulatory finding does not prove that a specific vial contains microbial contaminants or bacteria. A non-sterile injectable can still carry a risk of infection. No illnesses were reported in the sources used here. This recall is Class II. FDA defines Class II as a recall where use of the product may cause temporary or medically reversible harm. It also covers cases where serious harm is remote.
What to Do With an Affected Vial
Neither FDA nor the firm had published patient instructions at the time of reporting. USA Today advised patients with an affected lot to stop using it and contact their prescriber. Some patients reported that their prescribers advised them to return the affected vials or dispose of the medication.
Questions about a specific vial belong with a licensed clinician or pharmacist. So do symptoms after a dose.
As a general safety precaution, symptoms such as fever, redness, swelling, or pain at an injection site warrant prompt contact with a clinician.
Compounded vs Brand-Name Drug Recalls
A compounded drug recall follows a different administrative path than a recall involving commercially manufactured, brand-name pharmaceuticals. Brand-name medications undergo pre-market approval by the FDA. When a commercial manufacturer issues a recall, the manufacturer runs the recall and its lots are posted by the FDA. In contrast, compounded preparations are customized medications formulated by compounding pharmacies for individual patient prescriptions. Compounded drugs do not receive FDA pre-market approval. A compounding pharmacy recall usually runs through the pharmacy and the prescribers who wrote the orders.
The affected vials may have been dispensed through telehealth or clinic prescribers, so a patient may not know which pharmacy filled it.
Timeline and Where to Verify
Apothecary Pharma initiated this voluntary recall on September 24, 2026, and notified customers by letter. Quartz reported that FDA did not issue a press release. Prior to this event, the FDA issued a warning letter to Apothecary Pharma in December 2025 citing deficiencies related to sterile drug production processes.
Patients and healthcare providers can verify current recall entries using public federal tracking tools. You can search by firm name or lot number on the FDA Enforcement Report search database. You can also monitor wider drug alerts through the official index of FDA recalls, market withdrawals and safety alerts.
What to Look For in a Body-Composition Scale
A bioimpedance scale trends body fat and muscle rather than just weight — useful when the number stalls but your composition is improving. The absolute body-fat % isn't lab-accurate, so use it for TRENDS at a consistent time of day. Choose one that syncs to an app so you can watch the trend line.
Frequently Asked Questions
Is my compounded tirzepatide part of the Apothecary Pharma recall?
Your vial is only part of this recall if it was compounded by Apothecary Pharma of Cary, North Carolina, and carries a lot number between AP-202622 and AP-202644 with a beyond-use date between October 7 and November 26, 2026. Check the exact list in the FDA Enforcement Report.
What should I do if my vial matches a recalled lot number?
USA Today advised patients with a recalled lot to stop using the vial and contact their prescribing clinician or dispensing pharmacy. Some patients reported that their prescribers advised them to return the medication or dispose of it. If you have experienced any adverse reactions, contact a licensed healthcare provider.
Does a lack of sterility assurance mean the medication is contaminated?
A lack of sterility assurance means the pharmacy cannot show the batch was made and tested to be sterile. It does not automatically mean that a specific vial contains bacteria or contaminants, and no patient illnesses were reported in the sources reviewed.
Where can I find the lot number on my tirzepatide prescription?
The lot number is printed directly on the vial label alongside the beyond-use date. If the label is missing or unreadable, inspect the outer carton or pharmacy label. You can also ask the dispensing pharmacy for the lot.
What is an FDA Class II drug recall?
An FDA Class II recall is an administrative classification indicating that exposure to or use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
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