Information
Ascend Laboratories Recalls Dabigatran Etexilate Capsules
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0739-2026Drug / Pharmaceutical
Ascend Laboratories Recalls Dabigatran Etexilate Capsules
Ascend Laboratories, LLC · Class III — Regulatory
Product Description
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Reason for 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
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
USA Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Ascend Laboratories, LLC on July 16, 2026. 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. This recall covers 936 cartons x 12 x 3 x 10 (in blister pack), distributed in USA Nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.