FDA recalls more than 7,000 bottles of antidepressant duloxetine over toxic chemical

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

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

The FDA issued the recall due to the presence of N-nitroso-duloxetine above the proposed interim limit. N-nitroso-duloxetine is toxic if swallowed and suspected of causing cancer, according to the National Library of Medicine.

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

The recall is designated as a Class II, meaning the product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the FDA.

N-nitroso-duloxetine is a chemical compound that can increase the risk cancer if consumed at elevated concentrations, according to the FDA.

The FDA did not issue specific guidance on what to do with the recalled duloxetine. Patients who take this medication should contact their health care provider.