Drug Recall: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS,
Ascend Laboratories, LLC · July 16, 2026
Reason for Recall
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 Description
Dabigatran Etexilate Capsules, 75 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 0904-7253-68.
Distribution
USA Nationwide
States Affected
NATIONWIDE
Quantity Affected
924 cartons x 12 x 6 x 10 (in blister pack)
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0738-2026
Status: ongoing
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