Dabigatran Etexilate Capsules — Class III drug recall D-0737-2026
Ongoing recall by Ascend Laboratories, LLC, reported 2026-08-05, distributed nationwide. Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Imp
| Recall number | D-0737-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Bedminster, NJ, United States |
| Recall initiated | 2026-07-16 |
| Classified | 2026-08-05 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00904-7253, 00904-7253-04, 00904-7253-35, 00904-7253-68, 00904-7254, 00904-7254-35, 00904-7254-68, 00904-7255, 00904-7255-10, 00904-7255-35, 00904-7255-68 |
| Lot numbers | 25141583 |
| Expiration dates | 2027-04-30 |
Product
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Reason for recall
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
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-0737-2026. 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.