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Low risk Drugs & MedicationsClass III

Dabigatran Etexilate 75 mg Recall

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories

Updated July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 60-count blister packs are being recalled because stability testing found impurities that exceeded acceptable limits. The medication may not work as reliably as intended.

Is the Ascend Laboratories, LLC recalled? Yes. This product was recalled by FDA on July 16, 2026. Details below.

What is recalled

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10) blister pack in a carton, prescription only, NDC 0904-7253-68, manufactured by Alkem Laboratories Ltd., Mumbai, India, and distributed by Major Pharmaceuticals, Indianapolis, IN 46268.

Am I affected

You are affected if you have a prescription for Dabigatran Etexilate 75 mg capsules in a 60-count blister pack with NDC number 0904-7253-68 or from a prescription filled through Major Pharmaceuticals.

What to do right now

Contact your pharmacy or doctor about your Dabigatran Etexilate prescription. Do not stop taking the medication without medical guidance. Your doctor will advise whether your supply is affected and if you need a replacement.

The hazard

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

Brands affected

Ascend Laboratories, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0738-2026
Classification
Class III
Recalled
July 16, 2026
Read the official notice

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