Dabigatran Etexilate — Class II drug recall D-0130-2025
Ongoing recall by Ascend Laboratories, LLC, reported 2024-12-18, distributed nationwide. CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
| Recall number | D-0130-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2024-12-12 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 10,444 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 67877-0474, 67877-0474-60, 67877-0475, 67877-0475-60, 67877-0624, 67877-0624-31, 67877-0624-60 |
| Lot numbers | 24142192, 24142193, 24142194, 24142463 |
| Expiration dates | 2026-04-30, 2026-05-31 |
Product
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
Reason for recall
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0130-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.