Dabigatran etexilate Capsules recall
Ascend Laboratories, LLC recalled Dabigatran etexilate Capsules on July 29, 2026 because of 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. It was sold nationwide.
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's recalled
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
Quantity: 1,753 cartons
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-0735-2026
- Source
- U.S. Food and Drug Administration
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