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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: 25141707, Exp 4/30/2027.
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 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.

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, 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
NDC0904-7254-68
Show the full FDA record
Full product labelDabigatran 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.
Recalling firmAscend Laboratories, LLC
DistributionUSA Nationwide
Quantity1,753 cartons
Recall initiated2026-06-30
Report date2026-07-29
Recall completed—
Recall numberD-0735-2026
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.