Prescription blood thinner recalled nationwide, FDA warns

The U.S. Food and Drug Administration says some dabigatran capsules have been recalled nationwide. Dabigatran, sold under the brand name Pradaxa, is an anticoagulant used to help reduce the risk of stroke and blood clots, particularly in patients with nonvalvular atrial fibrillation. The recall is limited to certain lots of dabigatran etexilate capsules manufactured by Alkem Laboratories Ltd. and distributed by Major Pharmaceuticals. FDA reports the affected lots failed impurity and degradation testing, but the agency has not yet assigned a risk level, leaving uncertainty about potential adverse effects. The recall covers 75 mg and 150 mg capsules in 60-count blister packs and 75 mg 30-count blister packs, listing specific lot numbers and expiration dates.