FDA Recall D-0310-2025

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class II Ongoing 419 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

Quantity: 13,128 100-Count Bottles

Reason for recall

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

Recall record

Recall number: D-0310-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide.
Recall initiated: 2025-03-21
Classified by FDA Center: 2025-04-04
FDA published: 2025-04-16
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): VENLAFAXINE
Generic name(s): VENLAFAXINE
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 68382-018, 68382-019, 68382-020, 68382-021, 68382-101
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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