Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules
- Recalling company
- Ascend Laboratories, LLC
- Product
- Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jul 16, 2026
- Reported
- Aug 5, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 936 cartons x 12 x 3 x 10 (in blister pack)
- Lot / codes
- Lot: 25141586, Exp. April 30, 2027.
- Company location
- Bedminster, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0739-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0739-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.