FDA Drug recall D-0002-2026
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus P…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus P… by Zydus Pharmaceuticals Usa, citing failed impurity/degradation specifications:Out of Specification result for an individual organic impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0002-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-24 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
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.
Reason
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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#: E409309, Exp 12/31/2026 |
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-0002-2026%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.