Apotex Corp.

19 FDA enforcement actions

19 Total Recalls

2 Class I

15 Class II

2 Class III

Firm Details

Product Types: drug
States: FL

All Recalls

Class II: Risk 09/05/2025 drug

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 09/05/2025 drug

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 05/28/2025 drug

Lack of Assurance of Sterility
Class II: Risk 05/28/2025 drug

Lack of Assurance of Sterility
Class II: Risk 05/28/2025 drug

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II: Risk 05/28/2025 drug

Lack of Assurance of Sterility
Class II: Risk 02/09/2024 drug

CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II: Risk 11/01/2023 drug

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II: Risk 11/01/2023 drug

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II: Risk 11/01/2023 drug

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II: Risk 11/01/2023 drug

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II: Risk 04/26/2023 drug

Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Class II: Risk 03/01/2023 drug

Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class III: Low Risk 12/21/2022 drug

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Class II: Risk 07/07/2022 drug

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Class III: Low Risk 05/03/2022 drug

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class II: Risk 03/31/2021 drug

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Class I: Dangerous 02/02/2021 drug

Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Class I: Dangerous 02/02/2021 drug

Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.