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-0735-2026Drug / Pharmaceutical
Ascend Laboratories Recalls Dabigatran etexilate Capsules
Ascend Laboratories, LLC · Class III — Regulatory
Product Description
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.
Reason for 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.
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
Ascend Laboratories, LLC initiated a Class III recall of a pharmaceutical product on June 30, 2026 affecting 1,753 cartons. 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 recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed in USA Nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.