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.
Class III · Ongoing
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
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Affected lots / codes — check yours against thisLot: 25141586, Exp. April 30, 2027.
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Classification
- Class III (unlikely to cause harm)
- Status
- Ongoing
- Quantity
- 936 cartons x 12 x 3 x 10 (in blister pack)
- Distribution
- USA Nationwide
- Recall initiated
- July 16, 2026
- Classified
- August 5, 2026
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0739-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0739-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
See every recall for this brand: Is DABIGATRAN ETEXILATE recalled? →
Check this brand across all 8 databases →