Ascend Laboratories, Llc: Dabigatran Etexilate Capsules, 150 Mg, 60-count (6x10) Blister Pack Further

Recall Summary Ascend Laboratories is recalling Dabigatran Etexilate 150 mg capsules (60-count blister packs) distributed nationwide because testing found the medication contained higher levels of impurities and degradation products than allowed. The affected medication was manufactured by Alkem Laboratories Ltd. in India and distributed by Major Pharmaceuticals, identified by NDC number 0904-7255-68.

Recalling firm

Ascend Laboratories, LLC

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.

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

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-07-16

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/52db0e1a-8080-442c-8417-97aae541f8e0