FDA Drug recall D-0656-2025
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Phar…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Phar… by Zydus Pharmaceuticals Usa, citing failed Impurity/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0656-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-04 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason
Failed Impurity/Degradation Specifications
Identifiers
| ndc | 68382-920-06 |
|---|---|
| ndc | 68382-920-16 |
| ndc | 68382-920-01 |
| ndc | 68382-920-30 |
| ndc | 68382-920-77 |
| ndc | 68382-921-06 |
| ndc | 68382-921-16 |
| ndc | 68382-921-01 |
| ndc | 68382-921-30 |
| ndc | 68382-921-77 |
| code_info | Lot E309376; Exp 11/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0656-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.