Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured b
Recalled August 5, 2026 · FDA recall D-0739-2026 · 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
936 cartons x 12 x 3 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, 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.
Manufacturer(s)
Ascend Laboratories, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →