Thousands of bottles of the antidepressant duloxetine, 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 Oct. 10 recall is due to the presence of N-nitroso-duloxetine, a chemical that is toxic if swallowed and suspected to cause cancer, according to the National Library of Medicine. The FDA classified the recall as Class II, meaning the drug could cause “temporary or medically reversible adverse health effects.”
The drug, manufactured by Towa Pharmaceutical Europe, was distributed nationwide in the U.S., according to the recall notice.
Towa and the FDA did not immediately respond to requests for comment.
Duloxetine reminder
The recall affects 7,107 bottles of duloxetine, the FDA said. The bottles contain 500 20 mg delayed-release 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 in people with diabetes, notes the Mayo Clinic. It is also used for people with fibromyalgia and chronic pain related to bones and muscles, it adds.
