Heart and Blood Thinner Medication Recalled Nationwide, FDA Says

More than 5,000 packages of dabigatran etexilate were recalled due to possible impurities.

Medications are stored on shelves at a pharmacy in Los Angeles on May 12, 2025. Eric Thayer/Getty Images

A drug manufacturer is recalling more than 5,000 packages of a heart and blood-thinning medication due to purity concerns, according to the Food and Drug Administration.

According to the FDA notice published in the week of Aug. 5, dabigatran etexilate capsules manufactured by India-based Alkem Laboratories Ltd. are being recalled.

The medication was distributed across the United States by Indianapolis-based Major Pharmaceuticals. The recall affects three lots of drugs distributed nationwide.

Overall, 5,460 cartons of medication were recalled due to “failed impurity/degradation specification,” suggesting that a batch of the drug that was tested showed elevated impurities, according to the notice.

The 12-month stability testing showed levels of Impurity II, Impurity III, and total impurities above the regulator’s acceptable specifications, according to the notice, but did not provide further details on these impurities.

Dabigatran etexilate is used to decrease the risk of stroke and blood clots in people with a heart rhythm problem called nonvalvular atrial fibrillation, according to the Mayo Clinic’s website. It’s also used to prevent or treat blood clots from happening again in people who have received other types of medicines, as well as to prevent deep vein thrombosis and pulmonary embolisms after hip replacement surgery.

An abstract from a study published by the American Heart Association shows that the medication, which is known by the name Pradaxa, is an anticoagulant that inhibits or slows the formation of blood clots. Anticoagulants are also called blood thinners.

Alkem Laboratories did not respond to a request for comment by publication time.

List of Products Under Recall

The recalled products came in cartons that used blister packs, according to the notice. They include:

• Dabigatran etexilate in 150 milligrams (mg) capsules, 60-count: Lot 25141583, and an expiration date of April 2027

• Dabigatran etexilate in 75 milligrams (mg) capsules, 60-count: Lot 25141585, and an expiration date of April 2027

• Dabigatran etexilate in 75 milligrams (mg) capsules, 30-count: Lot 25141586, and an expiration date of April 2027

The FDA has not yet classified the recall as of Wednesday.

Other Recalls

Alkem Laboratories in July recalled one lot of amlodipine and olmesartan medoxomil tablets—in 10 mg and 20 mg doses, respectively—used to treat high blood pressure and heart attacks. The reason for the recall was due to “failed dissolution specifications,” an FDA-published notice said.

In May, the company also recalled more than 17,000 bottles of metoprolol succinate extended-release tablets, which are used to treat high blood pressure, also due to a “dissolution failure.”

Meanwhile, in September 2025, the company recalled more than 140,000 bottles of the generic version of atorvastatin, a commonly prescribed drug for treating cholesterol and heart issues. A similar problem was cited for the recall at the time.