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.
Reported: October 8, 2025 Initiated: September 24, 2025 #D-0001-2026
Product Description
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.
Reason for Recall
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 912 30-count bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 912 30-count bottles.
Why was this product recalled? ▼
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 8, 2025. Severity: Moderate. Recall number: D-0001-2026.
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