Stroke and blood clot drug recalled for an impurity volume that can increase cancer risk

Ascend Laboratories has recalled 10 lots of Dabigatran Etexilate capsules, used to lower the risk of blood clots and strokes, after finding the nitrosamine in the drug was above the FDA’s acceptable daily intake level.

Here’s what you need to know.

What Dabigatran is being recalled?

This involves two strengths of Dabigatran.

The recalled 75 mg capsules, NDC No. 67877-474-60, are lot Nos. 22142462, 22142463, and 22142464, expiration May 2024; 221430000, 22143001 and 221430002, expiration June 2024.

The label for Dabigatran Etexilate capsules 75 mg
The label for Dabigatran Etexilate capsules 75 mg

The recalled 150 mg strength capsules, NDC No. 67877-475-60, are lot Nos. 22142448, 22142449, and 22142450, expiration May 2024; and 22143845, expiration, July 2024.

The label for Dabigatran Etexilate capsules 150 mg
The label for Dabigatran Etexilate capsules 150 mg

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Why is it being recalled?

There’s too much of the nitrosamine N-nitroso-dabigatran.


“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables,” the Ascend-written, FDA-posted recall notice said. “Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

What should you do now?

First, don’t panic — you’re not getting cancer from these capsules tomorrow. In fact, Ascend’s recall notice advises to keep taking the medication until you and your medical care provider come up with a different treatment.

If you have questions about this recall, call Ascend at 877-272-7901.

If you’ve had any medical problems from this or any other drug, first see a medical professional. Then, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Only then do you call the manufacturer, in this case Ascend Laboratories at the above phone number.

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