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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

168

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 141–160 of 168 recalls

Paroxetine Tablets (Zydus) – Foreign Tablet Contamination (2017)

Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets

Class IIModerate

FDANov 20, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Paroxetine Tablets 30mg (Zydus) - Foreign Tablets Found (2017)

Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets

Class IIModerate

FDAAug 18, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Testosterone Cypionate Progesterone (Fusion IV) – CGMP deviation (2017)

CGMP Deviations

Class II

1...6 789

Page 8 of 9Next

Moderate

FDAJul 12, 2017CA, IN• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Fludeoxyglucose F 18 Injection (Lantheus) – Solvent Impurity (2017)

Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent

Class IIILow

FDAMay 18, 2017PR• Lantheus MI Radipharmaceuticals Inc.

Divalproex Sodium Tablets 250mg (Zydus Pharmaceuticals) – Dissolution Failure (2017)

Failed Dissolution Specifications

Class IIModerate

FDAMay 10, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Divalproex Sodium Tablets (Zydus) – Failed Dissolution (2017)

Failed Dissolution Specifications

Class IIModerate

FDAMay 10, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Divalproex Sodium Tablets 125mg (Zydus Pharmaceuticals) – Dissolution Failure (2017)

Failed Dissolution Specifications

Class IIModerate

FDAMay 10, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Divalproex Sodium Tablets (Zydus) – Failed Dissolution (2017)

Failed Dissolution Specifications; 9 month long term stability

Class IIModerate

FDAMar 15, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Atenolol Tablets (Zydus Pharmaceuticals) - Foreign Tablet Mix-up (2017)

Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.

Class IIModerate

FDAMar 6, 2017Nationwide• Zydus Pharmaceuticals USA Inc

Bupropion Hydrochloride Tablets (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications; 6 month time point

Class IIILow

FDANov 2, 2016Nationwide• Zydus Pharmaceuticals USA Inc

BuPROPion (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

Class IIILow

FDAAug 3, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Venlafaxine HCL ER 150mg (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Class IIModerate

FDAJul 19, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Venlafaxine HCL ER Capsule (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Class IIModerate

FDAJul 19, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Trokendi XR Capsules (Supernus) – Superpotent Drug Issue (2016)

Superpotent Drug: Failure of assay specifications in the capsule.

Class IIModerate

FDAJul 12, 2016Nationwide• Supernus Pharmaceuticals, Inc.

Remeven Cream (Stratus) – product crystallization (2016)

Crystallization; Complaints that cream appears to have crystallized

Class IIILow

FDAMay 26, 2016Nationwide• Stratus Pharmaceuticals Inc

Bromocriptine Mesylate Capsules 5mg (Zydus) – Impurity Specifications (2016)

Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.

Class IIModerate

FDAMay 9, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Risperidone Orally Disintegrating Tablets 2mg (Zydus) – impurity specs (2016)

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

Class IIILow

FDAJan 14, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Benzonatate Capsules (Zydus Pharmaceuticals) – Wet Capsules (2014)

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

Class IIModerate

FDADec 23, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Benzonatate Capsules (Zydus) – Wet Capsules (2014)

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

Class IIModerate

FDANov 26, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Amlodipine Besylate Tablets (Zydus) – Tablet Discoloration (2014)

Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.

Class IIILow

FDAOct 1, 2014Nationwide• Zydus Pharmaceuticals USA Inc