Home / Recalls / Zydus Pharmaceuticals (USA) Inc / D-0657-2025

D-0657-2025 Class II Ongoing

Recalled by Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Recall Details

Product Type: Drugs
Report Date: September 24, 2025
Initiation Date: September 4, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4440 bottles

Product Description

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

Reason for Recall

Failed Impurity/Degradation Specifications

Distribution Pattern

U.S. Nationwide

Code Information

Lot E309377, Exp 11/30/2025

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D-0400-2026 Class II — Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured (March 9, 2026)
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D-0247-2026 Class III — traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufacture (December 19, 2025)
D-0159-2026 Class II — Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Man (October 23, 2025)
D-0153-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottle (October 22, 2025)
D-0152-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottle (October 22, 2025)
D-0154-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottle (October 22, 2025)
D-0001-2026 Class II — Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus (September 24, 2025)
D-0002-2026 Class II — Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus L (September 24, 2025)
D-0656-2025 Class II — Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Life (September 4, 2025)