Ascend Laboratories: Multiple Dabigatran Etexilate Capsules
Ascend Laboratories is recalling 110 mg and 150 mg Dabigatran etexilate capsules due to failed impurity and degradation specifications.
Contact your healthcare provider or pharmacist to discuss alternative treatment options and return the affected medication to your pharmacy.
Why it was recalled
Ascend Laboratories is recalling Dabigatran etexilate capsules in 110 mg and 150 mg strengths due to failed impurities and degradation specifications. Out-of-specification results were observed during stability testing for Impurity II, Impurity III, and total impurities.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Dabigatran etexilate Capsules
| Strength | NDC / UPC |
|---|---|
| 150 mg | NDC 0904-7255-10 |
| 110 mg | NDC 0904-7254-68 |
Official source
Other recent recalls from Ascend Laboratories, LLC
Editorial summary by Recall Canary · last updated 2026-07-20 · primary source: U.S. Food and Drug Administration