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Apothecary Pharma recalls 22 compounded tirzepatide vials over sterility doubts

The Class II recall also covers one vial of NAD+ injection, and the Cary, North Carolina outsourcing facility drew an FDA warning letter in December 2025.

MH
By Maren Holt · Senior Reporter, GLP-1
Oct 26 07:31 ETSource: Medical Daily

The wire

  1. 01The firm voluntarily recalled 18 mg/mL tirzepatide in 4 mL multidose vials, NDC 85091-001-18, lots AP-202622 to AP-202644 with beyond-use dates of October 7 to November 26, 2026, plus NAD+ lot AP-202647.
  2. 02Pharmacies and telehealth programs dispensing compounded tirzepatide should check lot numbers; multidose vials punctured repeatedly carry added infection risk when sterility assurance fails.
  3. 03No illnesses have been reported and FDA classified the recall Class II on October 8; the notice says only that vials went nationwide, without patient counts or states.

From the source

Compounded Tirzepatide Vials From Cary, North Carolina Compounder Recalled Nationwide Over Sterility Doubts, With No Illnesses Reported

Apothecary Pharma, a drug compounder in Cary, North Carolina, is recalling 22 vials of compounded tirzepatide distributed nationwide because their sterility cannot be assured. The recall also includes one vial of an NAD+ injection, and no illnesses or injuries have been reported, according to the FDA recall notice summarized by LiveNOW from FOX .

Read at medicaldaily.com
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