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Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc Recalls

All product recalls associated with Zydus Pharmaceuticals (USA) Inc.

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Recall Summary

Total Recalls

33

Past Year

26

Class I (Serious)

0

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–33 of 33 recalls

Esomeprazole Magnesium Suspension 20mg (Zydus) – Impurity Specification (2025)

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 IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Esomeprazole Magnesium Suspension 40mg (Zydus) – Impurity Specification (2025)

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 IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

ChlorproMAZINE Tablets (Zydus) – Impurity Above Limit (2025)

12

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CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Venlafaxine Tablets (Zydus) – Foreign Material Risk (2025)

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Class IIModerate

FDAMar 21, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Esomeprazole Oral Suspension (Zydus) – Incorrect NDC Number (2024)

Labeling: Not Elsewhere Classified - Wrong NDC number

FDANov 14, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Micafungin Injection (Zydus Pharmaceuticals) – Cross Contamination (2024)

Cross contamination with other products

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Micafungin Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc