Apothecary Pharma recalls compounded tirzepatide vials over sterility assurance
FDA classified the nationwide recall of 22 vials as Class II on October 8, nearly a year after a warning letter citing sterile production failures.
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By Maren Holt · Senior Reporter, GLP-1
Oct 21 08:05 ETSource: ConsumerAffairs
The wire
- 01Apothecary Pharma of Cary, North Carolina is recalling Tirzepatide Injection 18 mg/mL in 4 mL multidose vials, NDC 85091-001-18, lots AP-202622 through AP-202644 excluding AP-202626.
- 02Compounders and telehealth prescribers dispensing these lots should identify affected patients; FDA-approved Mounjaro and Zepbound are not involved, and diabetes patients need a replacement plan.
- 03The recall is listed as ongoing and follows a December 1, 2025 FDA warning letter citing obstructed protective airflow, inadequate glove sanitation and rusty surfaces; no contamination has been confirmed.
From the source
Read at consumeraffairs.comCompounded GLP-1 weight-loss drug recalled over sterility concerns
Apothecary Pharma is recalling compounded tirzepatide injections distributed nationwide because their sterility cannot be assured.
