Dabigatran Etexilate Capsules recall
Ascend Laboratories, LLC recalled Dabigatran Etexilate Capsules on August 5, 2026 because of 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. It was sold nationwide.
Why it was recalled
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
What's recalled
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
Quantity: 924 cartons x 12 x 6 x 10 (in blister pack)
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Ascend Laboratories, LLC, Bedminster, NJ
- Date
- Severity
- Class III
the product is unlikely to cause health problems but breaks a rule. - Where sold
- Nationwide
USA Nationwide - Status
- Ongoing
- Recall number
- D-0738-2026
- Source
- U.S. Food and Drug Administration
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