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.
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
| Recalling firm | Ascend Laboratories, LLC |
|---|---|
| Reason | 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 |
| Risk class | Class III (Class III · low) |
| Status | Ongoing |
| Report date | Aug 5, 2026 |
| Initiated | Jul 16, 2026 |
| Region | NJ, United States |
| Distribution | USA Nationwide |
| Quantity | 3,600 cartons x 6 x 10 (in blister pack) |
| Code/Lot | Lot: 25141583, Exp. April 30, 2027. |
| Type | Voluntary: Firm initiated |
| Recall number | D-0737-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0737-2026)
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