Antidepressant Duloxetine Recalled Due to Toxic Chemical – NBC Chicago

The U.S. Food and Drug Administration has recalled thousands of bottles of the antidepressant drug duloxetine due to the presence of a toxic chemical.

According to an Oct. 10 release from the agency, the recall involves 7,107 bottles of duloxetine, sold under the brand name Cymbalta. According to the FDA, duloxetine belongs to a class of medications called selective serotonin/norepinephrine reuptake inhibitors (SNRIs) that are used to treat depression, anxiety, and other mood disorders.

The FDA announced the recall because the level of N-nitroso-duloxetine was above the proposed interim limit. According to the National Library of Medicine, N-nitroso-duloxetine is toxic if swallowed and is suspected of causing cancer.

The recalled capsules have a strength of 20 mg and are sold in bottles of 500. The lot number of the recalled products is 220128 with an expiration date of December 2024 and is manufactured by Towa Pharmaceutical Europe, according to the FDA.

The recall is classified as a Class II product, meaning the product “may cause temporary or medically reversible adverse health effects or the likelihood of serious adverse health effects is remote,” according to the FDA.

N-nitroso-duloxetine is a chemical compound that the FDA says may increase the risk of cancer when consumed in elevated concentrations.

The FDA has not issued specific guidance on what to do with the recalled duloxetine. Patients taking this medication should consult their doctor.