FDA recall, , Low risk
Ascend Laboratories Dabigatran Etexilate Capsules
Dabigatran Etexilate Capsules failed impurity and degradation specifications.
Summary by Recall Canary from the FDA notice
What happened
Ascend Laboratories, LLC of Bedminster, New Jersey recalled Dabigatran Etexilate Capsules because the product failed impurity and degradation specifications. The recall began July 16, 2026 and was added to the FDA's Enforcement Report on July 24, 2026, involving 75 mg and 150 mg strengths distributed nationwide. The reason was an out-of-specification result in related substance test analysis for Impurity II, Impurity III, and total impurities under long-term stability conditions.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UPC is the number printed under a barcode.
Dabigatran Etexilate Capsules
- Strength
- 75 mg
- UPC
- 25141586
- Strength
- 75 mg
- UPC
- 25141585
- Strength
- 150 mg
- UPC
- 25141583
From the FDA notice
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Ascend Laboratories, LLCBedminster, New Jersey
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99421
- Recall numbers
- D-0737-2026 to D-0739-2026
All recalls from Ascend Laboratories, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA · In FDA's weekly enforcement report
Summary updated
