US Drug Recall Register
Class III · Low risk Ongoing Initiated Jun 30, 2026 (2 months ago)

Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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.

What was recalled

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.

Recalling firm
Ascend Laboratories, LLC
NDC code
0904-7255-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0736-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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