Compounded Tirzepatide Recall: Which Vials Are Affected and What Is Known

A North Carolina compounding pharmacy has recalled injectable drugs nationwide, including compounded versions of the GLP-1 medication tirzepatide, because their sterility cannot be assured, according to a Food and Drug Administration notice reported by USA Today, Fox Business and Cardinal & Pine.

Apothecary Pharma LLC, based in Cary, began the voluntary recall on Sept. 24. The FDA has classified it as Class II, a category the agency uses when serious health consequences are considered unlikely. The notice did not identify any illnesses or injuries linked to the recall, Fox Business reported.

What was recalled?

The main product is Apothecary Pharma Tirzepatide Injection, an 18 mg/mL prescription solution sold in a 4 mL multidose vial. Tirzepatide is the active ingredient in Eli Lilly's Mounjaro and Zepbound, but the recalled product is a compounded version, not a brand-name drug.

According to Fox Business, the recall also covers one vial of NAD+ injection, a 200 mg/mL prescription product in a 6 mL multidose vial, lot AP-202647, with a beyond-use date of Oct. 13, 2026. Fox Business put the total at 23 vials. The other outlets focused only on the tirzepatide.

Which lots are affected?

The tirzepatide lots are AP-202622 through AP-202625 and AP-202627 through AP-202644, according to Fox Business. Their beyond-use dates run from Oct. 7 through Nov. 26, 2026. Cardinal & Pine and USA Today published the full list of lots and dates from the FDA notice.

The FDA notice lists 22 vials of tirzepatide. USA Today reported that the lot codes suggest the figure may actually refer to 22 lots rather than 22 vials. The outlet said it asked the FDA to clarify.

Why was the product recalled?

The FDA notice cites a "lack of assurance of sterility." Reports differ on the date of the Class II designation: Cardinal & Pine and USA Today say Oct. 10, while Fox Business says Oct. 8.

The recall follows a December 2025 FDA warning letter to the company. It cited several violations, including serious deficiencies in how the company makes drugs meant to be sterile, which the agency said "put patients at risk." Fox Business reported that the FDA has not established a connection between those findings and the current recall.

USA Today said it contacted Apothecary Pharma and the FDA on Oct. 19 and had not received a response.

Is there a conflicting explanation?

Yes. USA Today reviewed a notice from NewLife Rx, a fulfillment service that distributed some of the vials. It said Apothecary told the service the recall was a documentation issue. The notice described the recall as occurring at the retail level, which it said does not require patients to stop using or return their medication.

USA Today noted that neither the FDA nor Apothecary has publicly or directly told customers the reason for the recall or whether the products are safe. It added that a Class II classification does not mean there are no risks.

What does this mean for patients?

People who received compounded tirzepatide, or the NAD+ injection, from Apothecary Pharma can compare the lot number and beyond-use date on their vial with the recall list. Fox Business reported that consumers should check their vials or pharmacy records, stop using affected products and contact a pharmacist or prescriber. USA Today and Cardinal & Pine likewise reported that anyone with an affected lot should consult a prescriber or health care provider before using it.

The FDA and Apothecary had not issued public, product-specific instructions on returning or discarding vials, according to Cardinal & Pine and USA Today. Both outlets said some customers have reported online that their prescribers asked them to return or discard the medication. Fox Business said anyone who develops fever, redness, swelling or worsening pain after an injection from an affected product should seek medical advice.

Why are compounded GLP-1 drugs under scrutiny?

Compounding pharmacies make customized medications, and the FDA does not review each compounded formulation for safety, effectiveness and quality before it is sold. During drug shortages, these pharmacies have helped fill gaps in supply. Tirzepatide and semaglutide were removed from the federal shortage list in late 2024 and early 2025, and the FDA has since paid closer attention to compounded versions. According to USA Today, many pharmacies kept producing them, and drugmakers including Eli Lilly and Novo Nordisk have sued compounders over the practice.

Both Cardinal & Pine and USA Today pointed to a past contamination case as an example of the risks: a 2012 fungal meningitis outbreak linked to a compounding pharmacy. Cardinal & Pine said readers can check a compounding pharmacy's reputation through the Alliance for Pharmacy Compounding website or by asking their prescriber.

Is the recall over?

No. Fox Business reported that Apothecary Pharma notified recipients by letter and that the recall remains ongoing.

Sources: Cardinal & Pine, USA Today, Fox Business