Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured
Recalled August 5, 2026 · FDA recall D-0737-2026 · Ascend Laboratories
Hazard
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 · FDA Class III
Units
3,600 cartons x 6 x 10 (in blister pack)
Sold at
USA Nationwide
Description
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
Product
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Manufacturer(s)
Ascend Laboratories, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →