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 81–89 of 89 recalls

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

Benzonatate Capsules (Zydus) – Capsule Mixing (2014)

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

Class III

1...3 45

Page 5 of 5Next

Low

FDASep 24, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Topiramate (Zydus) – Tablet Mix-up (2014)

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Class IIModerate

FDASep 15, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Atenolol Tablets (Zydus) – Superpotent Drug Concern (2014)

Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.

Class IIModerate

FDAAug 5, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Promethazine Tablets (Zydus) – Foreign Tablet Mix (2014)

Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

Class IIModerate

FDAMay 8, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Warfarin Sodium Tablets (Zydus) – Tablet Specification Issue (2013)

Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

Class IHigh

FDAMay 13, 2013Nationwide• Zydus Pharmaceuticals USA Inc

Venlafaxine Tablets (Zydus) - Broken Tablet Defect (2013)

Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.

Class IIModerate

FDAMar 5, 2013Nationwide• Zydus Pharmaceuticals USA Inc

Metformin Tablets (Zydus Pharmaceuticals) – Foreign Substance (2012)

Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.

Class IIModerate

FDAMar 14, 2012Nationwide• Zydus Pharmaceuticals USA Inc