Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, IND
Summary
The FDA issued a Class III for Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufact by Ascend Laboratories, LLC. Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity.
Details
Source
Drug Recall
External ID
D-0735-2026
Action Date
2026-07-29
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: 25141707, Exp 4/30/2027.
Quantity Affected: 1,753 cartons
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.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-30
Company
Bedminster, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 45 drug recalls issued in the same week, part of 63 drug-related FDA actions this month.
Ascend Laboratories, LLC has 34 FDA actions in our database, including 34 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ascend Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ascend Laboratories, LLC have FDA actions?
Ascend Laboratories, LLC has 34 FDA actions in our database, including 34 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0735-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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