Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distribut
Summary
The FDA issued a Class II for Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesc by Zydus Pharmaceuticals (USA) Inc. Reason: Failed Impurity/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0657-2025
Action Date
2025-09-24
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot E309377, Exp 11/30/2025
Quantity Affected: 4440 bottles
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-04
Company
Pennington, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 68 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zydus Pharmaceuticals (USA) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zydus Pharmaceuticals (USA) Inc have FDA actions?
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0657-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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