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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

Past Year

Class I (Serious)

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 41–60 of 89 recalls

Fulvestrant Injection (Zydus) – Impurity Specification (2022)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJul 15, 2022Nationwide• Zydus Pharmaceuticals (USA) Inc

Carvedilol 25mg Tablets (Zydus) – Foreign Tablet Contamination (2021)

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

Class IIModerate

FDAAug 13, 2021Nationwide• Zydus Pharmaceuticals (USA) Inc

Acyclovir Sodium 1000mg (Zydus) – Product Crystallization (2021)

Crystallization: customer complaints for crystallization in finished product.

Class I

1 234 5

Page 3 of 5Next

High

FDAFeb 18, 2021Nationwide• Zydus Pharmaceuticals (USA) Inc

Acyclovir Sodium 500mg (Zydus) – Product Crystallization (2021)

Crystallization: customer complaints for crystallization in finished product.

Class IHigh

FDAFeb 18, 2021Nationwide• Zydus Pharmaceuticals (USA) Inc

Lansoprazole ODT 15mg (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIModerate

FDADec 3, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Lansoprazole ODT 30mg (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIModerate

FDADec 3, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Lansoprazole ODT (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specification

Class IIModerate

FDAOct 27, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Lansoprazole ODT (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specification

Class IIModerate

FDAOct 27, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Ethacrynate Sodium Injection (Zydus) – cGMP Deviation (2020)

cGMP Deviations

Class IIModerate

FDAJan 31, 2020Nationwide• Zydus Pharmaceuticals USA Inc