Drug Enforcement D-0657-2025

Failed Impurity/Degradation Specifications

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

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Product Information

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.
Product quantity
4440 bottles
Reason for recall
Failed Impurity/Degradation Specifications
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0657-2025
Event ID
97556
Recall initiation date
September 4, 2025
Center classification date
September 18, 2025
Code info
Lot E309377, Exp 11/30/2025
More code info
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