FDA Enforcement Report Details Ongoing Class III Recall of Dabigatran Etexilate Capsules
FDA enforcement records detail an ongoing recall of 2,717 cartons of Dabigatran etexilate Capsules distributed nationwide.
4 reports on this incident · first at Aug 20, 2026, 2:19 a.m. ET
Earlier reports
Aug 20, 2026, 2:52 a.m. ET
FDA Classifies Ongoing Recall of Dabigatran Etexilate Capsules as Class III
On July 29, 2026, the FDA classified an ongoing recall of Dabigatran etexilate Capsules as Class III under recall number D-0736-2026. According to the agency's definitions, Class III is the FDA's least serious category, used where using the product is not likely to cause harm.
The recall was initiated on June 30, 2026, by Ascend Laboratories, LLC of Bedminster, for 2,717 cartons distributed USA Nationwide. The affected product is Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, manufactured by Alkem Laboratories in Mumbai, INDIA, and distributed by Major Pharmaceuticals in Indianapolis, IN 46268 (NDC 0904-7255-10). The recall covers Lot: 25141584 with an expiration date of Exp 4/30/2027.
According to the FDA enforcement report, the reason for the ongoing recall is Failed Impurities/Degradation Specifications after an 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. The agency's database records no other enforcement action by Ascend Laboratories, LLC.
Aug 20, 2026, 2:22 a.m. ET
FDA Closes Recall of Dabigatran Etexilate Capsules
The Food and Drug Administration has closed its Class III recall action for 2,717 cartons of Dabigatran etexilate Capsules, 150 mg, as of July 29, 2026. Closing the action indicates that the FDA considers the recall carried out. The action, designated recall number D-0736-2026, was reported on July 29, 2026, after being initiated on June 30, 2026, by Ascend Laboratories, LLC, based in Bedminster.
The nationwide recall affected 20-count cartons (2x10) of Rx-only Dabigatran etexilate Capsules, 150 mg, bearing NDC 0904-7255-10, Lot 25141584, and expiration date Exp 4/30/2027. The drug was manufactured by Alkem Laboratories in Mumbai, India, and distributed by Major Pharmaceuticals in Indianapolis, IN 46268.
According to FDA enforcement documentation, the recall was initiated due to failed impurities/degradation specifications after an out-of-specification result was observed during related substance test analysis regarding Impurity II, Impurity III, and Total impurity testing for 12 Month Long-Term Stability. Class III is the FDA's least serious category, defined as a situation where using the product is not likely to cause harm. The agency's database lists no other enforcement action for Ascend Laboratories, LLC.
Aug 20, 2026, 2:19 a.m. ETFirst report
FDA Enforcement Report Details Ongoing Class III Recall of Dabigatran Etexilate Capsules
In an FDA enforcement report dated July 29, 2026, the agency documented an ongoing Class III recall of Dabigatran etexilate Capsules, 150 mg, initiated on June 30, 2026, by Ascend Laboratories, LLC of Bedminster. The nationwide recall applies to 2,717 cartons.
The affected product is packaged as 20-count cartons (2x10), Rx only, with NDC 0904-7255-10, manufactured by Alkem Laboratories in Mumbai, India, and distributed by Major Pharmaceuticals in Indianapolis, Indiana. According to official FDA enforcement records, the recall covers Lot 25141584 with an expiration date of 4/30/2027. The agency report states the reason for the recall as failed impurities/degradation specifications after an out-of-specification result was observed during related substance test analysis for Impurity II, Impurity III, and total impurity testing for 12-month long-term stability.
Class III is the FDA's least serious recall category, defined by the agency as a situation where using or exposure to a violative product is not likely to cause adverse health consequences. According to FDA database records, Ascend Laboratories, LLC has no other enforcement actions listed. The event remains open and ongoing.
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