Ascend Dabigatran Etexilate 75mg Recall
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie
Updated July 16, 2026
Dabigatran Etexilate 75 mg capsules are being recalled because impurities in the drug exceeded safe limits during stability testing. The medication may not work as intended or could be less safe to use.
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, 30-count (3x10) blister pack, NDC 0904-7253-04, manufactured by Alkem Laboratories Ltd. in Mumbai, India, and distributed by Major Pharmaceuticals in Indianapolis, Indiana.
Am I affected
You're affected if you have a prescription for Dabigatran Etexilate 75 mg capsules in a 30-count blister pack with NDC number 0904-7253-04.
What to do right now
Stop taking this medication and contact your doctor or pharmacy right away. Do not throw away the capsules; return them to your pharmacy or follow your pharmacy's instructions for safe disposal. Your doctor can prescribe a replacement or alternative anticoagulant.
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-0739-2026
- Classification
- Class III
- Recalled
- July 16, 2026
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