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Thousands of bottles of popular antidepressant recalled: 3 things to know
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Thousands of bottles of popular antidepressant recalled: 3 things to know

Thousands of bottles of a popular antidepressant are being recalled due to the presence of what the National Library of Medicine describes as a toxic chemical, according to a notice from the U.S. Food and Drug Administration.

The recall involves the drug duloxetine, which is sold under the brand name Cymbalta, according to the FDA’s notice of the voluntary recall, which began Oct. 10.

Duloxetine is part of a class of drugs known as SNRIs, or selective serotonin/norepinephrine reuptake inhibitors, which are used to treat anxiety, depression, and other mood disorders, according to the FDA.

Here are three things consumers should know about the recall.

1. How do I know if my medication is subject to the recall?

The recall involves 7,101 bottles of delayed-release duloxetine capsules, which are distributed nationwide in the United States, according to the FDA.

The recalled capsules have a strength of 20 mg and are sold in bottles of 500.

The lot number of the recalled capsules is 220128, with an expiration date of December 2024, according to the FDA notice.

The recalled capsules are manufactured by Towa Pharmaceutical Europe.

In an emailed statement, Towa Pharmaceutical Europe referred ABC News to the FDA’s website on nitrosamine impurities in medications. N-nitrosoduloxetine is a type of nitrosamine.

“Regarding nitrosamine impurities in medications, the FDA continues to say that ‘patients taking prescription medications with possible nitrosamine impurities should not stop taking their medications. Patients should talk to their healthcare professionals about their concerns and other treatment options,” Towa Pharmaceutical Europe said in a statement. “The FDA also said it is ‘working to determine the source of these impurities and will keep the public informed.’”

2. What is the potentially toxic chemical that prompted the recall?

According to the recall notice, the recalled duloxetine capsules were found to contain a higher level of N-nitroso-duloxetine than permitted.

N-nitrosoduloxetine is a chemical compound that can be toxic if ingested in high concentrations and is suspected to cause cancer, according to the U.S. National Library of Medicine.

The FDA has designated the voluntary recall of duloxetine bottles as a Class II recall. The agency defines this as “a situation in which use of or exposure to an infringing product may cause temporary or medically reversible adverse health effects or where the likelihood of serious adverse health effects is remote.”

3. What should I do if my medication is part of the recall?

The voluntary recall notice shared by the FDA does not provide specific instructions on what to do with recalled duloxetine capsules.

Because of the potential risk of side effects, a person should consult their doctor before suddenly stopping or changing the administration of an antidepressant.

Editor’s note: This report has been updated to include a statement from Towa Pharmaceutical Europe.