Generic Cymbalta recall affects 7,000+ bottles, FDA says

Generic Cymbalta recall overview:

• Who: Thousands of bottles of duloxetine, the generic version of the antidepressant Cymbalta, have been recalled.
• Why: The drug contains a toxic chemical.
• Where: The generic Cymbalta recall is active across the United States.

Thousands of bottles of duloxetine, the generic version of the antidepressant Cymbalta, are being recalled due to the presence of a toxic chemical.

The recall was published to the Food and Drug Administration (FDA) website on Oct. 10. It applies to 7,107 bottles of duloxetine, the FDA said. 

According to the recall, the product contains 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, which means that the drug could cause “temporary or medically reversible adverse health consequences.”

Despite this, the FDA said it recommends patients talk to their health care professional about the best course of action for their health if they have a medication that has been recalled, including whether to stop using the medication or not.

The medication, manufactured by Towa Pharmaceutical Europe, was distributed nationally throughout the U.S. The bottles include 500 delayed-release 20mg capsules. The lot number is 220128, with an expiration date of 12/2024.

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

Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSRI), is prescribed for anxiety and depression. It can also be used to treat nerve pain for people with diabetes, or for people with fibromyalgia and chronic pain related to bones and muscles.

In June, Glenmark Pharmaceuticals and American Health Packaging recalled 141 batches and 21 batches of Potassium Chloride Extended-Release Capsules over concerns the medication has a failed dissolution, which could cause patients to develop high potassium levels. 

Are you affected by this generic Cymbalta recall? Let us know in the comments.

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