Ascend Laboratories, Llc: Dabigatran Etexilate Capsules, 75 Mg, 60-count (6x10)blister Pack

Ascend Laboratories is recalling Dabigatran Etexilate Capsules 75 mg (a blood thinner medication) because testing found higher-than-acceptable levels of impurities in batches stored under standard long-term conditions. The affected product is a 60-count blister pack distributed in the United States. This recall applies to patients who have prescriptions for this medication.

Recalling firm

Ascend Laboratories, LLC

Product

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

Reason

Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-07-16

Status

Ongoing

Distribution

Within the U.S Market.

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

Recall details on Nibble Recalls: https://trynibble.app/recalls/91e951e6-2fef-4cff-875d-f70c43bb831e