Dabigatran etexilate Capsules, 150 mg, 20-count carton… was recalled on June 30, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity…
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Lot: 25141584, Exp 4/30/2027.
Units affected: 2,717 cartons
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 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.
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.
View official notice →The recalled bicycles' front lock nut can loosen during use, causing the front wheel to dislodge or loosen over time, posing a crash hazard.
When plugged in or switched on, the lamp cord or internal wiring can smoke, melt, spark, overheat or ignite, posing a risk of serious injury from fire and burn hazards.
Failed Content Uniformity Specifications
Failed Impurities/Degradation Specifications
Be the first to know when products like this are recalled. Free weekly digest, unsubscribe anytime.