FDAFDA · Food and drugs·Recall number D-0735-2026
Dabigatran 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.
Published July 29, 2026 · Recall initiated: June 30, 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 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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- USA Nationwide
- UPC
- 0309047253043
- Lot
- Lot: 25141707, Exp 4/30/2027.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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