Thousands of duloxetine bottles, an antidepressant sold as Cymbalta, recalled over toxic chemical

Thousands of bottles of the antidepressant duloxetine, which is sold under the brand name Cymbalta, have been recalled due to the presence of a toxic chemical, according to a notice from the Food and Drug Administration. 

The October 10 recall is due to the presence of N-nitroso-duloxetine, a chemical that is toxic if swallowed and is suspected of causing cancer, according to the National Library of Medicine. The FDA classified the recall as Class II, which means that the drug could cause “temporary or medically reversible adverse health consequences.”

The medication, manufactured by Towa Pharmaceutical Europe, was distributed nationally throughout the U.S., according to the recall notice.

Towa and the FDA didn’t immediately respond to requests for comment.

Duloxetine recall

The recall covers 7,107 bottles of duloxetine, the FDA said. The bottles include 500 delayed-release 20mg capsules. The lot number is 220128, with an expiration date of 12/2024.

Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSRI), is prescribed for anxiety and depression, and can also be used to treat nerve pain for people with diabetes, the Mayo Clinic notes. It’s also used for people with fibromyalgia and chronic pain related to bones and muscles, it adds.