Thousands of bottles of duloxetine, an antidepressant sold as Cymbalta, have been recalled because of toxic chemicals

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 statement 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 is suspected of causing 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 throughout the United States, according to the recall notice.

In a statement emailed to CBS MoneyWatch, the FDA said it “recommends patients speak with their doctor about the best course of action for their health if they receive a recalled drug.”

Towa Pharmaceutical sent a statement pointing to the FDA's comment as well as an agency recommendation that patients taking prescriptions “containing potential nitrosamine contaminants” should not stop taking their medications.

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

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

Duloxetine recall

The recall affects 7,107 bottles of duloxetine, the FDA said. The bottles contain 500 20 mg sustained-release capsules. The batch number is 220128, the expiration date is 12/2024.

Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSRI), is prescribed for anxiety and depression and may 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 bone and muscle pain, they say.

Aimee Picchi

Aimee Picchi is Associate Managing Editor at CBS MoneyWatch, where she covers business and personal finance. She previously worked at Bloomberg News and has written for national news outlets such as USA Today and Consumer Reports.