D-0737-2026 Class III Ongoing
FDA drug recall D-0737-2026 was initiated by Ascend Laboratories, LLC on July 16, 2026 and is designated Class III. 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 The recall status is ongoing. Affected quantity: 3,600 cartons x 6 x 10 (in blister pack).
Recall Details
- Product Type
- Drugs
- Report Date
- August 5, 2026
- Initiation Date
- July 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,600 cartons x 6 x 10 (in blister pack)
Product Description
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
Distribution Pattern
USA Nationwide
Code Information
Lot: 25141583, Exp. April 30, 2027.