Reported Sep 24, 2025 · Ongoing
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India,…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only
- Manufactured byZydus Lifesciences Ltd., Ahmedabad, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06
- Lot codes and dates
Lot E309376Exp 11/30/2025
- Amount recalled
- 4344 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specifications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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