FDA classifies Apothecary Pharma compounded tirzepatide recall as Class II
The North Carolina pharmacy pulled 18 mg/mL multidose vials over lack of sterility assurance, a year after an FDA warning letter cited sterile-production deficiencies.
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By Daniel Okafor · Regulatory Correspondent
Oct 21 02:25 ETSource: Baller Alert
The wire
- 01Apothecary Pharma LLC began a voluntary recall September 24, 2026 of compounded tirzepatide injection, 18 mg/mL in 4 mL sterile multidose vials; the FDA classified it Class II on October 8.
- 02The recall covers compounded product only, not Mounjaro or Zepbound, and follows a December 2025 FDA warning letter citing rusty equipment, poor glove sanitization and inadequate airflow testing after a May 2025 Cary facility inspection.
- 03The FDA has not confirmed contamination; Class II means temporary or reversible harm is possible and serious harm remote. Affected October lots run AP-202622 through AP-202630.
From the source
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