Zydus Pharmaceuticals (USA) Inc

46 FDA enforcement actions

46 Total Recalls

2 Class I

35 Class II

9 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 12/30/2025 drug

Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
Class III: Low Risk 12/19/2025 drug

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II: Risk 10/23/2025 drug

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class II: Risk 10/22/2025 drug

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II: Risk 10/22/2025 drug

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II: Risk 10/22/2025 drug

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II: Risk 09/24/2025 drug

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II: Risk 09/24/2025 drug

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II: Risk 09/04/2025 drug

Failed Impurity/Degradation Specifications
Class II: Risk 09/04/2025 drug

Failed Impurity/Degradation Specifications
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 09/03/2025 drug

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II: Risk 08/27/2025 drug

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Class II: Risk 05/30/2025 drug

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class II: Risk 05/13/2025 drug

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II: Risk 05/13/2025 drug

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II: Risk 04/03/2025 drug

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II: Risk 03/21/2025 drug

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Class II: Risk 02/13/2025 drug

Failed Impurities/Degradation Specifications
Class II: Risk 02/13/2025 drug

Failed Impurities/Degradation Specifications
Class III: Low Risk 11/14/2024 drug

Labeling: Not Elsewhere Classified - Wrong NDC number
Class III: Low Risk 07/02/2024 drug

Cross contamination with other products.
Class III: Low Risk 07/02/2024 drug

Cross contamination with other products.
Class III: Low Risk 07/02/2024 drug

Cross contamination with other products
Class III: Low Risk 07/02/2024 drug

Cross contamination with other products
Class II: Risk 06/27/2024 drug

Presence of particulate matter: glass
Class II: Risk 06/21/2024 drug

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class III: Low Risk 05/16/2024 drug

Failed Impurities/Degradation Specifications.
Class III: Low Risk 05/16/2024 drug

Failed Impurities/Degradation Specifications.
Class II: Risk 10/19/2023 drug

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II: Risk 10/19/2023 drug

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II: Risk 10/19/2023 drug

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II: Risk 09/21/2023 drug

Failed Dissolution Specifications
Class III: Low Risk 02/24/2023 drug

Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Class II: Risk 07/15/2022 drug

Failed Impurities/Degradation Specifications
Class II: Risk 08/13/2021 drug

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Class I: Dangerous 02/18/2021 drug

Crystallization: customer complaints for crystallization in finished product.
Class I: Dangerous 02/18/2021 drug

Crystallization: customer complaints for crystallization in finished product.

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.