Thousands of bottles of the antidepressant duloxetine have been recalled across the United States after tests revealed higher-than-allowed levels of a potentially cancer-causing impurity. The voluntary recall affects duloxetine delayed-release capsules, a generic form of the brand-name drug Cymbalta, commonly prescribed for depression, anxiety, and certain types of chronic pain.
According to the U.S. Food and Drug Administration, the affected capsules may contain excess amounts of N-nitroso-duloxetine, which is part of a group of compounds known as nitrosamines. Nitrosamines have been classified as probable human carcinogens, meaning long-term exposure above recommended limits could increase the risk of cancer. The recall includes both the 30mg and 60mg capsule varieties, covering nearly 375,000 bottles distributed nationwide. The medication was manufactured by Towa Pharmaceutical in Spain and distributed in the U.S. by Breckenridge Pharmaceutical Inc.
The recall is classified as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences, according to the FDA. There have been no reports of adverse effects linked to the recalled duloxetine so far.
Patients currently using duloxetine are urged not to stop taking their medicine abruptly, as doing so can lead to withdrawal symptoms. Instead, they should consult their healthcare provider for guidance. Pharmacists and healthcare professionals should check their inventory and follow FDA instructions for returning or disposing of the recalled product. More information and specific lot numbers can be found on the FDA’s official recall page.
This is not the first time duloxetine capsules have been recalled due to nitrosamine concerns. A similar recall involving thousands of bottles was conducted in 2024.
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