Multi event Drug Recall Enforcement Report Class II voluntary initiated by Zydus Pharmaceuticals (USA) Inc, originally initiated on 09-24-2025 for the product 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. The product was recalled due to failed impurity/degradation specifications:out of specification result for an individual organic impurity. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0001-2026 | 09-24-2025 | 10-08-2025 | Class II | 912 30-count bottles | 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. | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Ongoing |
| D-0002-2026 | 09-24-2025 | 10-08-2025 | Class II | 600 30-count bottles | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Ongoing |
Recalled Products
