Thousands of bottles of the antidepressant duloxetine have been recalled because they contain levels of a potentially cancer-causing impurity above federal safety limits, according to a notice from the U.S. Food and Drug Administration.
Duloxetine is a prescription medication used to treat depression and anxiety. The affected pills were voluntarily recalled by manufacturer Towa Pharmaceutical and are distributed by Breckenridge Pharmaceutical Inc.
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The recall was issued due to the presence of N-nitroso-duloxetine, an impurity found in the drug at levels that exceed the FDA’s recommended limit.
According to the FDA, exposure to nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
The agency notes that people exposed to these impurities at or below the acceptable daily intake limit are not expected to have an increased risk of cancer.
Anastasiia Voloshko/Getty Images – stock photo of a person holding tablets and a medicine bottle, representing personal healthcare, treatment, and responsible medication use at home
While there is no specific evidence linking N-nitroso-duloxetine directly to cancer, it belongs to a class of compounds known as nitrosamines, some of which are considered probable human carcinogens.
Health risks associated with these substances generally depend on the amount and duration of exposure, with higher levels over longer periods posing a greater concern.
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The FDA classified the action as a Class II recall, meaning use of or exposure to the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
ABC News has reached out to the company for comment but did not hear back immediately.
