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Class III · Lower riskActive recall

Dabigatran Etexilate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot: 25141583, Exp. April 30, 2027.
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAlkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 foreign manufacturer
Brand nameDABIGATRAN ETEXILATE
Generic nameDABIGATRAN ETEXILATE
Active ingredient(s)DABIGATRAN ETEXILATE MESYLATE
Distributed by / forMAJOR PHARMACEUTICALS, Indianapolis, IN 46268
NDC0904-7255-68
Show the full FDA record
Full product labelDabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Recalling firmAscend Laboratories, LLC
DistributionUSA Nationwide
Quantity3,600 cartons x 6 x 10 (in blister pack)
Recall initiated2026-07-16
Report date2026-08-05
Recall completed—
Recall numberD-0737-2026
ClassificationClass III
FDA statusOngoing
Origin on fileBedminster NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.