Dabigatran Etexilate Capsules, 75 mg, 60-count… was recalled on July 16, 2026 in cooperation with the U.S. Food and Drug Administration because failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and…
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.
Lot: 25141585, Exp. April 30, 2027.
Units affected: 924 cartons x 12 x 6 x 10 (in blister pack)
Where it was sold: USA Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
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
Class III means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Ascend Laboratories, LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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