Ascend Laboratories, Llc: Dabigatran Etexilate Capsules, 110 Mg, 60-count Carton (6x10)

Recall Summary Ascend Laboratories is recalling Dabigatran etexilate Capsules 110 mg (60-count cartons) distributed nationwide because testing found the medication failed to meet purity standards—it contained higher-than-acceptable levels of impurities and degradation products during stability testing. This is a Class III recall, meaning the product is unlikely to cause serious health problems. The affected medication was manufactured by Alkem Laboratories in India and distributed by Major Pharmaceuticals.

Recalling firm

Ascend Laboratories, LLC

Product

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

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/0b4fc19a-2ab6-4dc9-8938-5e1a768db268