Ascend Laboratories recalls Dabigatran Etexilate Capsules 75 mg and 150 mg over failed impurity test
A 12-month stability test found impurity levels in these dabigatran etexilate capsules were out of specification for Impurity II, Impurity III and total impurities.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.; Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd.…
- Company
- Ascend Laboratories, LLC
- Hazard
- 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
- Units
- 924 cartons x 12 x 6 x 10 (in blister pack); 936 cartons x 12 x 3 x 10 (in blister pack); 3,600 cartons x 6 x 10 (in blister pack)
- Where sold
- USA Nationwide
- FDA classification
- Class III · Ongoing
- Classified by FDA
- August 5, 2026
- Recall started
- July 16, 2026
- FDA enforcement report
- August 5, 2026
- Identifiers
- Codes: Lot: 25141585, Exp. April 30, 2027.
- FDA recall number: D-0738-2026
- Codes: Lot: 25141586, Exp. April 30, 2027.
- FDA recall number: D-0739-2026
- Codes: Lot: 25141583, Exp. April 30, 2027.
- FDA recall number: D-0737-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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. | 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, Indianapolis, IN 46268, NDC 0904-7253-04. | 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.
- Reason for recall
- 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
- Classification
- Class III (Ongoing)
- Distribution
- USA Nationwide
- Quantity
- 924 cartons x 12 x 6 x 10 (in blister pack); 936 cartons x 12 x 3 x 10 (in blister pack); 3,600 cartons x 6 x 10 (in blister pack)
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