Ascend Laboratories: Multiple Dabigatran Etexilate Capsules
Ascend recalls Dabigatran Etexilate Capsules (150 mg, 75 mg) over impurity/degradation failures.
Check your prescription bottle for the affected NDC and lot codes. Contact your pharmacy or Ascend Laboratories for return and replacement instructions. Do not take capsules from recalled lots.
Why it was recalled
Ascend Laboratories is recalling Dabigatran Etexilate Capsules in 150 mg and 75 mg strengths due to failed impurity/degradation specifications. Long-term stability testing at 12 months showed out-of-specification results for Impurity II, Impurity III, and total impurities. The recall includes 150 mg 60-count blister packs and 75 mg 30-count and 60-count blister packs.
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 |
|---|---|
| 75 mg | NDC 0904-7253-04 |
| 150 mg | NDC 0904-7255-68 |
| 75 mg | NDC 0904-7253-68 |
Official source
Other recent recalls from Ascend Laboratories, LLC
Editorial summary by Recall Canary · last updated 2026-07-26 · primary source: U.S. Food and Drug Administration