Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Zydus Pharmaceuticals USA Inc

Zydus Pharmaceuticals USA Inc Recalls

All product recalls associated with Zydus Pharmaceuticals USA Inc.

Get alerts for this brand

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 61–80 of 89 recalls

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Anastrozole Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class II

1 2 345

Page 4 of 5Next

Moderate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Acyclovir Tablets (Zydus) – Label Mix-up (2019)

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Class IIModerate

FDAApr 25, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Carvedilol Tablets (Zydus) – Label Mix-up (2019)

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Class IIModerate

FDAApr 25, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Carvedilol Tablets (Zydus Pharmaceuticals) – Foreign Tablet Contamination (2019)

Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.

Class IIILow

FDAApr 22, 2019Nationwide• Zydus Pharmaceuticals USA Inc

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

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 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; 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 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

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

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