The U.S. Food and Drug Administration (FDA) has issued a recall for thousands of bottles of the antidepressant medication duloxetine, sold under the brand name Cymbalta, due to the presence of a potentially toxic chemical. The recall, which began on October 10, involves 7,101 bottles of duloxetine delayed-release capsules distributed nationwide within the United States. The recalled capsules are 20mg in strength, sold in 500-count bottles, with lot number 220128 and an expiration date of December 2024.
Duloxetine is part of a class of drugs known as SNRIs, or selective serotonin/norepinephrine reuptake inhibitors, used to treat anxiety, depression, and other mood disorders. The recalled capsules were found to contain a higher level of N-nitroso-duloxetine than is permitted. N-nitroso duloxetine is a chemical compound that can be toxic if swallowed in elevated concentrations and is suspected of potentially causing cancer, according to the U.S. National Library of Medicine.
The recalled capsules are manufactured by Towa Pharmaceutical Europe. In a statement, Towa Pharmaceutical Europe referred to the FDA’s website on nitrosamine impurities in medications and advised patients not to stop taking their medications without consulting their healthcare professionals.
The FDA has designated the voluntary recall of duloxetine bottles as a Class II recall, indicating that use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.
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