Apothecary Pharma recalls compounded tirzepatide vials over sterility concerns
The FDA has labelled the voluntary recall of 22 multi-dose vials Class II, following a December 2025 warning letter citing serious sterility deficiencies.
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By Daniel Okafor · Regulatory Correspondent
Oct 20 12:08 ETSource: pharmaphorum
The wire
- 01Cary, North Carolina-based Apothecary Pharma is recalling 22 sterile multi-dose vials of compounded tirzepatide, 18mg/mL in 4mL, after an FDA inspection found serious deficiencies in sterile production practices.
- 02The FDA classified the recall as Class II, indicating moderate risk of temporary or reversible harm, and continues to scrutinise compounded incretin supply following prior semaglutide recalls at Apollo Care, Idexis, ProRx and Aequita.
- 03Compounders have kept selling under Section 503A personalisation exceptions by altering strengths or adding components such as vitamin B12; litigation between manufacturers and compounders is ongoing.
From the source
Read at pharmaphorum.comCompounded tirzepatide recalled after FDA warning
A compounded version of Eli Lilly's injectable weight-loss and diabetes therapy tirzepatide, produced and sold by Apothecary Pharma, has been recalled from sale in the US over sterility concerns.
