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
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0738-2026
- Classification
- Class III
- Recalled
- July 16, 2026
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