Recall
FDAHealthMarch 21, 2025

Zydus Pharmaceuticals (USA) Inc — Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0

⚠️ Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 21, 2025

US Nationwide.

What's affected?

Product
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
UPC
0368382019011
Lot code
M314265

Additional details

Lot #: M314265, Exp.: 31 October 2025.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 13,128 100-Count Bottles.

View original FDA notice →

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