Patients should check their vial labels and contact their pharmacist or prescriber if their medication matches the affected products.
Apothecary Pharma has voluntarily recalled certain compounded tirzepatide and NAD+ injections distributed nationwide because their sterility cannot be assured, according to an October 21 report from FOX 13, citing FDA recall records.
The North Carolina company began the recall September 24 and notified recipients by letter, the report said. The FDA classified the action as Class II on October 8.
The reported recall concerns specific Apothecary Pharma products. It does not identify branded Mounjaro or Zepbound as recalled products, although those medicines also contain tirzepatide.
Which Products Are Affected?
Patients can compare their medication labels or pharmacy records with the following details reported by FOX:
| Product detail | Compounded tirzepatide | NAD+ injection |
|---|---|---|
| Strength | 18 mg/mL | 200 mg/mL |
| Packaging | 4 mL multidose vial | 6 mL multidose vial |
| NDC number | 85091-001-18 | 85091-011-06 |
| Affected lots | AP-202622 through AP-202625; AP-202627 through AP-202644 | AP-202647 |
| Beyond-use dates | October 7–November 26, 2026 | October 13, 2026 |
The lot ranges matter: AP-202626 is not included in the list supplied in the report. Anyone unsure about a label should ask the dispensing pharmacy to check its records.
What the Sterility Concern Means
Injectable medicines must be sterile. A lack of sterility assurance means that requirement cannot be reliably established; it does not, by itself, prove that every affected vial contains contamination.
FOX reported that the FDA notice did not list illnesses or injuries associated with the recalled products. That does not remove the need to follow the recall instructions.
The reported Class II designation should also not be read as a declaration that the products are safe to continue using. It describes the recall’s risk classification.
What Patients Should Do
People with a matching product should stop using the affected vial and contact their pharmacist or prescriber for instructions about replacement medication and how to return or dispose of it.
Keep the packaging or take clear photographs of the label so the pharmacy can confirm the product, strength, lot number and beyond-use date. Do not switch products or change a prescribed dose without guidance.
Anyone who develops fever, redness, swelling or worsening pain after an affected injection should seek medical attention, according to the consumer guidance in the FOX report.
FDA Previously Raised Concerns at the Facility
Separately, the FDA issued Apothecary Pharma a warning letter dated December 1, 2025. The agency described problems involving conditions and practices used to prepare drugs intended to be sterile, along with concerns about some corrective actions.
That letter provides background on the company’s regulatory history. It does not establish what caused this recall, and FOX reported that the agency had not linked the earlier findings to the current action.
For patients, the immediate step is a label check. The drug name alone is not enough to determine whether a medication is affected; the supplier, strength and lot number are essential.
