FDA recalls 7,000 bottles of antidepressant because of cancer-causing chemical

WASHINGTON (TNND) — Thousands of bottles of an antidepressant have been recalled by the US Food and Drug Administration due to a cancer-causing chemical.

The voluntary recall of 7,107 bottles of the generic form of Cymbalta, known as duloxetine, was initiated by Breckenridge Pharmaceutical Inc. on Oct. 10. The recall batch was number 220128 and expires in December 2024.

According to the Mayo Clinic, duloxetine is used to treat depression and anxiety, but it can also be used for pain caused by nerve damage associated with diabetes. The product description includes 20 mg bottles of 500 manufactured by Towa Pharmaceutical Europe.

The FDA found that the drug had an impurity in the drug's active ingredient, nitrosamine, which “may increase the risk of cancer when people are exposed to it at acceptable levels and for extended periods of time.”

Classified as a Class II recall, the FDA describes it as a “situation in which use of or exposure to an infringing product may cause temporary or medically reversible adverse health effects, or in which the likelihood of serious adverse health effects is remote.”

The FDA gave no guidance on what to do with the recalled drug. Patients should therefore contact their doctor.