FDAFDA · Food and drugs·Recall number D-0739-2026
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.
Published August 5, 2026 · Recall initiated: July 16, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- USA Nationwide
- UPC
- 0309047253043
- Lot
- Lot: 25141586, Exp. April 30, 2027.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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