LowFDAOngoing
Unlikely to harm you, but it breaks the rules. Your pharmacist can tell you more.
Dabigatran Etexilate Capsules, 75 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 0904-7253-68.
Check the label for
Lot: 25141585, Exp. April 30, 2027.
- Why
- 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
- Distributed
- USA Nationwide
- Company
- Ascend Laboratories, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222
Source: FDA record D-0738-2026 · retrieved 5 August 2026
Read the official notice