Ascend Laboratories, Llc: Dabigatran Etexilate Capsules, 150 Mg, 20-count Carton (2x10)

Dabigatran Recall Summary Ascend Laboratories is recalling Dabigatran etexilate 150 mg capsules (20-count cartons) distributed nationwide because testing found the medication contained higher-than-acceptable levels of impurities and degradation products. The affected medication was manufactured by Alkem Laboratories in India and distributed by Major Pharmaceuticals. This recall applies to patients across all U.S. states and territories who received this specific batch of the blood thinner medication.

Recalling firm

Ascend Laboratories, LLC

Product

Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

Reason

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

Classification

Class III

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-30

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/ff7aa25b-9616-48e2-9bba-e86d50645ff1