FDAHealthJuly 16, 2026
Ascend Laboratories, LLC — Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distribut
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 16, 2026
USA Nationwide
What's affected?
- Product
- Dabigatran 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.
- Brand
- DABIGATRAN ETEXILATE
- UPC
- 0309047253043
- Lot code
- 25141583
Additional details
Lot: 25141583, Exp. April 30, 2027.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 3,600 cartons x 6 x 10 (in blister pack).
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