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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.

Duloxetine is a medication mostly used for major depressive disorder, generalized anxiety disorder, fibromyalgia and neuropathic pain.
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The FDA is recalling more than 233,000 bottles of a leading antidepressant over potential cancer risk.

Overview

  • 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.