FDA Recalls Nearly 300,000 Blood Thinner Capsules

The recalled anti-coagulant is known by brand as Pradaxa and was distributed nationwide by Major Pharmaceuticals of Indianapolis in a total of 5,460 cartons.

Juliette Fairley

Published: 8/3/2026, 11:41:07 AM EDT

FDA Recalls Nearly 300,000 Blood Thinner Capsules — The logo of the U.S. Food and Drug Administration (FDA) is seen on a sign outside the agency's White Oak campus in Silver Spring, Md., on July 17, 2025. (Issam Ahmed/AFP via Getty Images)

The U.S. Food and Drug Administration (FDA) announced the recall of 299,520 capsules of a popular blood thinner prescribed within the U.S medical market.

Concerns about impurity and degradation led Alkem Laboratories Ltd. of Mumbai, India, to voluntarily recall three lots of Dabigatran Etexilate Capsules contained in 5,460 cartons, according to an FDA report.

The recalled anticoagulant is known by brand name as Pradaxa and was distributed nationwide by Major Pharmaceuticals of Indianapolis in a total of 5,460 cartons.

The withdrawal applies to 3,600 cartons of 150 mg, 60-count blister packs, 924 cartons of 75 mg, 60-count blister packs, and 936 cartons of 75 mg, 30-count blister packs.

“Failed impurity/degradation specification,” the FDA report states.

Specifically, 12-month stability testing revealed levels of Impurity II, Impurity III, and total impurities above acceptable specifications, according to the FDA.

The following three lot numbers are named in the recall: 25141583, 25141585, and 25141586.

The lots all expire on April 30, 2027.

Alkem Laboratories management did not respond to requests for comment by the time of publication.

Dabigatran is intended to decrease the risk of stroke and blood clots in patients with a serious heart rhythm problem, according to the Mayo Clinic.

It works by preventing clots from forming in the blood vessels.

Conditions dabigatran is prescribed for include atrial fibrillation, deep vein thrombosis and pulmonary embolism treatment and prevention as well as hip replacement prophylaxis.

Market data show that when it was approved by the FDA in 2010, dabigatran was the first direct oral anticoagulant to be promoted as an alternative to warfarin. Unlike dabigatran, warfarin requires routine blood monitoring.

The Centers for Disease Control and Prevention reports that up to 900,000 people in the United States are affected by blood clots and 3 in 10 people who suffer a blood clot will experience another episode within 10 years.

The FDA advises patients to consult their physician or pharmacist for an alternative prescription before stopping a blood thinner abruptly.

This is not the first time dabigatran has been recalled.

In March 2023, Ascend Laboratories issued a voluntary nationwide recall for generic dabigatran etexilate capsules.

That recall was prompted by elevated levels of a nitrosamine impurity called N-Nitroso-dabigatran. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables.

"Everyone is exposed to some level of nitrosamines,” the FDA said in its March 22, 2023 safety alert. “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”