FDA Recalls Over 233,000 Bottles of Antidepressant Duloxetine for Cancer-Causing Impurity

The recall, classified as a Class II risk, involves duloxetine capsules containing nitrosamine levels above acceptable limits.

The U.S. FDA has recalled 233,003 bottles of duloxetine capsules, citing the presence of N-nitroso-duloxetine, a potentially cancer-causing impurity.
The recall affects 30-count, 90-count, and 1000-count bottles of 60 mg duloxetine, manufactured by Rising Pharmaceuticals and distributed nationwide.
The impurity, a type of nitrosamine, can increase cancer risk if consumed above safe levels over prolonged periods, though the risk is considered low for short-term exposure.
The FDA classified the recall as Class II, indicating potential temporary or medically reversible adverse health effects, with a remote chance of severe consequences.
Patients using recalled duloxetine are advised to stop taking the medication and consult healthcare providers for alternative treatments.