Compounded Tirzepatide, NAD+ Injections Recalled Nationwide Over Sterility Concerns

North Carolina-based Apothecary Pharma is recalling 23 vials of injectable drugs distributed nationwide because their sterility cannot be assured, according to a Food and Drug Administration notice. The voluntary recall includes 22 vials of compounded tirzepatide and one vial of NAD+ injection.

Tirzepatide is the active ingredient in Mounjaro and Zepbound, which are not affected by the recall.

Recall Details

The company began the voluntary recall Sept. 24, and the FDA classified it as Class II on Oct. 8, according to Becker’s Hospital Review. A Class II recall applies to products that may cause temporary or medically reversible health effects, where the risk of serious harm is small. Apothecary Pharma notified recipients by letter, and the recall remains ongoing.

The FDA notice did not report any illnesses or injuries linked to the recalled products. It also did not say whether the injections were contaminated.

Affected Products

Tirzepatide injection, 18 mg/mL, 4 mL multidose vial (NDC 85091-001-18)

• Lots AP-202622 through AP-202625 and AP-202627 through AP-202644
  Beyond-use dates from Oct. 7 through Nov. 26, 2026

NAD+ injection, 200 mg/mL, 6 mL multidose vial (NDC 85091-011-06)

• Lot AP-202647
  Beyond-use date of Oct. 13, 2026

All recalled products were prescription only.

Prior FDA Warning

The FDA sent Apothecary Pharma a warning letter in December 2025 citing serious deficiencies in its sterile drug production practices. The agency said those issues put patients at risk. It has not connected those findings to the current recall.

What Med Spa Professionals Should Know

• Check your inventory. Compare any tirzepatide or NAD+ products from Apothecary Pharma against the NDC and lot numbers above.
• Remove affected vials. Separate any recalled product from usable inventory and follow the recall letter’s instructions. Contact the pharmacy or your supplier if you have questions about returns.
• Identify affected patients. Use your dispensing and administration records to find patients who received product from affected lots, and follow your medical director’s protocols for patient outreach.
• Review your sourcing. Recalls and warning letters are a reminder to verify the licensure and compliance history of every compounding pharmacy you work with. See AmSpa’s supplier verification checklist.