Thousands of bottles of the antidepressant duloxetine, the generic version of 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.

In an emailed statement to CBS MoneyWatch, the FDA said it “recommends patients talk to their healthcare provider about the best course of action for their health if they have a drug that has been recalled.”

Towa Pharmaceutical sent a statement referencing the FDA’s comment, as well as a recommendation from the agency that patients using prescriptions “with possible nitrosamine impurities should not stop taking their medications.”

The company noted that the FDA is investigating the source of the chemicals in the recalled duloxetine and referred customers to an agency website about nitrosamine impurities in medications.

People taking certain medications, including duloxetine, should not suddenly stop taking them due to the risk of side effects, according to Healthline.

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.

Aimee Picchi

Aimee Picchi is associate managing editor for CBS MoneyWatch, where she covers business and personal finance. She previously worked at Bloomberg News and wrote for national news outlets including USA Today and Consumer Reports.