Ascend Laboratories, LLC Dabigatran Etexilate Capsules Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot: 25141584, Exp 4/30/2027. |
|---|---|
| Lot / date codes | Lot: 25141585, Exp. April 30, 2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Ascend Laboratories, LLC recalls
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.