Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured b
Summary
The FDA issued a Class III for Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packa by Ascend Laboratories, LLC. Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurit.
Details
Source
Drug Recall
External ID
D-0739-2026
Action Date
2026-08-05
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: 25141586, Exp. April 30, 2027.
Quantity Affected: 936 cartons x 12 x 3 x 10 (in blister pack)
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
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-16
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 40 drug recalls issued in the same week, part of 59 drug-related FDA actions this month.
Ascend Laboratories, LLC has 36 FDA actions in our database, including 36 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 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0739-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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