FDA Drug recall D-0129-2025
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend La…
- FDA Drug
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend La… by Ascend Laboratories, citing CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0129-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-12 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Reason
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Identifiers
| ndc | 67877-475-60 |
|---|---|
| ndc | 67877-474-60 |
| ndc | 67877-624-60 |
| ndc | 67877-624-31 |
| code_info | Lot #: 24142328, 24142329, 24142330, Exp. Date May 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-0129-2025%22
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