Ascend Laboratories: Multiple Dabigatran Etexilate Capsules
Ascend recalls Dabigatran Etexilate 75mg/150mg capsules over impurity spec failures.
Check your prescription bottle for the affected NDC and lot numbers. Contact your pharmacy or Ascend Laboratories for a refund or replacement. Do not stop taking your medication without consulting your healthcare provider.
Why it was recalled
Ascend Laboratories is recalling Dabigatran Etexilate Capsules in 75 mg and 150 mg strengths, available in 30-count and 60-count blister packs, due to failed impurity/degradation specifications. Out-of-specification results were observed for Impurity II, Impurity III, and total impurities under long-term stability conditions.
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
| Lot code | Strength | NDC / UPC | UPC | Recall # |
|---|---|---|---|---|
| 25141586, 2027 | 75 mg | – | 25141586 | N/A |
| 25141586, 2027 | 75 mg | – | 25141586 | D-0739-2026 |
| – | 75 mg | – | 25141585 | D-0738-2026 |
| – | 150 mg | – | 25141583 | D-0737-2026 |
| 25141583, 2027 | 150 mg | NDC 0904-7255-68 | – | – |
| 25141585, 2027 | 75 mg | NDC 0904-7253-68 | – | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Impurity or Degradation recalls
Other recent recalls from Ascend Laboratories, LLC
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification