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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 161–168 of 168 recalls

Benzonatate Capsules (Zydus) – Capsule Mixing (2014)

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

Class IIILow

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 II

1...7 89

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Moderate

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

Benztropine Mesylate Injection (Nexus) – Glass Delamination (2013)

Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.

Class IIModerate

FDAAug 1, 2013Nationwide• Nexus Pharmaceuticals 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