Thousands of bottles of an antidepressant have been recalled by the U.S. Food and Drug Administration due to a cancer-causing chemical.
The voluntary recall for 7,107 bottles of the generic form of Cymbalta, known as Duloxetine, was initiated on Oct. 10 by Breckenridge Pharmaceutical Inc. The recall lot was #220128, expiring in December 2024.
Duloxetine is used to treat depression and anxiety but can also be used for pain caused by nerve damage associated with diabetes, according to the Mayo Clinic.
The product description includes 20 mg 500-count bottles manufactured by Towa Pharmaceutical Europe.
The FDA noted the medication had the presence of nitrosamine drug substance impurity which “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
Classified as a Class II recall, the FDA describes it as a “situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The FDA did not provide guidance on what to do with the recalled medicine, so patients should contact their health care provider.