Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.

FDA recall notice · announced August 5, 2026 · Ascend Laboratories

Not Yet Classified

The product

Reason for recall

Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities

Notes

Distribution: Within the U.S Market.
Lot/code information: Lot: 25141586, Exp. April 30, 2027.
Quantity: 936 cartons x 12 x 3 x 10 (in blister pack)
Status: Ongoing
Products in this recall event:
- Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC (N/A)
- 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, (D-0738-2026)
- 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 (D-0739-2026)
- 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 PHARMACEUTICAL (D-0737-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.