Ascend Laboratories, LLC Dabigatran Etexilate Capsules Recall (April 2027)
Announced 2026-08-05 · FDA
The FDA is recalling Ascend Laboratories, LLC Dabigatran Etexilate Capsules (75 mg, 60-count blister pack, Rx only) distributed nationwide in the United States; Lot 25141584, Exp 4/30/2027, involves 2,717 cartons. The recall is due to failed impurity/degradation specifications; an out-of-specification (OOS) result was observed for Impurity II, Impurity III and Total Impurity in the related substance test for 12-month long-term stability. Corrective action is not specified in the provided information.
| Brand | Ascend Laboratories, LLC |
|---|---|
| Product | Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10. |
| Reason | Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. |
| Severity | low |
| Units affected | 924 |
| Distribution | USA Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot: 25141584, Exp 4/30/2027. |
WHAT YOU SHOULD DO
- Do not use this recalled product if you have Lot 25141584.
- Contact your pharmacist or healthcare provider for guidance and possible alternatives.
- Return the recalled product to the place of purchase or follow FDA recall directions for disposal.
- Monitor for updates from FDA or the manufacturer and follow any new instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.