FDA-Drug2025-10-08Class IICHEMICAL
Zydus Entecavir 0.5 mg tablets recalled for failed impurity specifications
What this means
Zydus Pharmaceuticals is recalling one lot of Entecavir 0.5 mg tablets because testing found an organic impurity that exceeded acceptable limits. The affected lot (E409308, expiring 12/31/2026) was distributed nationwide. No injuries have been reported.
- Check if your Entecavir bottle matches lot #E409308
- Contact your pharmacist or doctor if you have this lot
- Do not stop taking Entecavir without medical guidance
- Return the recalled tablets to your pharmacy
The agency's original wording
Hazard
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
912 30-count bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2026Want us to check the next one for you?
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