FDA Recall D-0002-2026

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class II Ongoing 232 days on record

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

Product

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Lot / code: Lot#: E409309, Exp 12/31/2026

Quantity: 600 30-count bottles

Reason for recall

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Recall record

Recall number: D-0002-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA
Recall initiated: 2025-09-24
Classified by FDA Center: 2025-10-02
FDA published: 2025-10-08
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): ENTECAVIR
Generic name(s): ENTECAVIR
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 68382-920, 68382-921
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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