Ascend Laboratories: Multiple Dabigatran Etexilate Capsules
Ascend recalls Dabigatran etexilate capsules (110 mg, 150 mg) over impurity test failures.
Consumers should stop using the recalled capsules and contact their healthcare provider for guidance. Return the product to the place of purchase for a refund or replacement.
Why it was recalled
Ascend Laboratories is recalling Dabigatran etexilate Capsules, 110 mg and 150 mg strengths, due to failed impurities/degradation specifications. An out-of-specification result was observed during related substance testing for Impurity II, Impurity III, and total impurities at the 12-month long-term stability time point.
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 | UPC | Recall # |
|---|---|---|---|
| 25141584, 2027 | 150 mg | 25141584 | D-0736-2026 |
| 25141707, 2027 | 110 mg | 25141707 | D-0735-2026 |
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