← FDA ENFORCEMENT
D-0310-2025Class II

Zydus Pharmaceuticals (USA) Inc

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Completed
Report date
2025-04-16
Distribution
US Nationwide.
Firm state
NJ
Product quantity
13,128 100-Count Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.