Teva Pharmaceuticals USA

60 FDA enforcement actions

60 Total Recalls

1 Class I

55 Class II

4 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 01/18/2022 drug

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II: Risk 01/10/2022 drug

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III: Low Risk 01/07/2022 drug

Mislabeling
Class III: Low Risk 01/07/2022 drug

Mislabeling
Class II: Risk 12/31/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/31/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/16/2021 drug

Subpotent
Class II: Risk 12/08/2021 drug

Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Class III: Low Risk 10/28/2021 drug

Failed Impurities/Degradation Specifications
Class II: Risk 10/27/2021 drug

Labelling: Incorrect Exp. Date
Class II: Risk 09/22/2021 drug

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II: Risk 09/22/2021 drug

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II: Risk 09/22/2021 drug

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II: Risk 09/22/2021 drug

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II: Risk 09/22/2021 drug

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II: Risk 07/29/2021 drug

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class II: Risk 07/29/2021 drug

Lack of Assurance of Sterility
Class I: Dangerous 06/18/2021 drug

Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class II: Risk 04/26/2021 drug

Lack of Assurance of Sterility
Class II: Risk 04/26/2021 drug

Lack of Assurance of Sterility
Class II: Risk 04/26/2021 drug

Lack of Assurance of Sterility
Class II: Risk 04/26/2021 drug

Lack of Assurance of Sterility
Class II: Risk 04/26/2021 drug

Lack of Assurance of Sterility
Class III: Low Risk 03/04/2021 drug

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Class II: Risk 02/15/2021 drug

Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II: Risk 02/10/2021 drug

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

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.