FDA recall, , Low risk
Ascend Laboratories Dabigatran Etexilate Capsules
Dabigatran etexilate capsules failed impurity and degradation specifications during stability testing.
Summary by Recall Canary from the FDA notice
What happened
Ascend Laboratories, LLC of Bedminster, New Jersey is recalling Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10) and Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), distributed nationwide by Major Pharmaceuticals, Indianapolis, IN 46268.
The recall began June 30, 2026, after an out-of-specification result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. The products were added to the FDA's Enforcement Report on July 17, 2026, and classified by the FDA on August 4, 2026.
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
- 150 mg
- UPC
- 25141584
- Strength
- 110 mg
- UPC
- 25141707
From the FDA notice
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
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
- 99330
- Recall numbers
- D-0735-2026 to D-0736-2026
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
In FDA's weekly enforcement report
Classified by FDA
Summary updated
