Thousands of bottles of an antidepressant medication have been flagged for recall because they may contain elevated levels of a potentially cancer-causing compound, according to U.S. Food and Drug Administration notifications.
In a recall notification published June 4, the FDA reported that approximately 14,729 bottles of duloxetine delayed-release capsules were pulled from distribution in the U.S. due to an N-nitroso-duloxetine impurity — called nitrosamines — at levels exceeding the FDA’s “recommended interim limit.”
The recalled medication comes in 30 and 60-milligram dosages and 90- and 1,000-count packages distributed nationwide.
The FDA classified both recalls on June 8 as Class II, meaning there is a risk of “temporary or medically reversible adverse health consequence.”
The New Jersey-based Breckenridge Pharmaceutical announced the voluntary recall of the products via letter, according to the FDA. The drug is manufactured by Towa Pharmaceutical Europe, a pharmaceutical company based in Spain.
Duloxetine is a prescription medication used to treat depression, anxiety disorder, fibromyalgia, and diabetic nerve pain and is the generic equivalent of different brands, including Cymbalta, according to the Mayo Clinic.
While nitrosamines are common in water and foods and most people are exposed to them on some levels without serious risks, when taken over an extended period of time, they can increase the risk of cancer, according to the FDA.
In 2024, over 7,000 bottles of Duloxetine were recalled due to a N-nitroso-duloxetine impurity, USA Today reported.
Together, the two recalls affect approximately 374,405 bottles distributed nationwide.