FDA logs Class II recall of Apothecary Pharma compounded tirzepatide vials
The Cary, North Carolina outsourcing facility also pulled one vial of NAD+ injection, and had received an FDA warning letter over sterile production in December 2025.
MH
By Maren Holt · Senior Reporter, GLP-1
Oct 21 05:00 ETSource: Medical Daily
The wire
- 01Apothecary Pharma began a voluntary nationwide recall on Sept. 24 of 22 vials of tirzepatide injection 18 mg/mL in 4 mL multi-dose vials, lots AP-202622 through AP-202644 except AP-202626, for lack of assurance of sterility; FDA classified it Class II on Oct. 8.
- 02Beyond-use dates run Oct. 7 through Nov. 26, 2026, so mail-order patients may still hold affected vials; the recall also covers one NAD+ injection vial, lot AP-202647.
- 03The FDA record reports no confirmed contamination or linked infections, and the agency has not tied the recall to the May 2025 inspection findings cited in its Dec. 1, 2025 warning letter. The recall is listed as ongoing.
From the source
Read at medicaldaily.comNorth Carolina Compounder Recalls Tirzepatide Vials Nationwide Over Sterility Concerns, with Lots Dated Through Late November
Patients who get compounded weight-loss or diabetes shots by mail now have a recall to check against their vial labels. Apothecary Pharma LLC, an outsourcing facility in Cary, North Carolina, is recalling 22 multi-dose vials of compounded tirzepatide distributed nationwide because of a lack of assurance of sterility, according to the FDA Enforcement Report . Tirzepatide is the active ingredient in
