FDA: Thousands of Bottles of Popular Antidepressant Recalled Over Potentially Cancer-Causing Chemical

Thousands of bottles of the antidepressant medication duloxetine have been recalled, according to the Food and Drug Administration. The medication, sold under the brand name Cymbalta, contains a potentially carcinogenic substance, N-nitroso-duloxetine.

The recall affects 7,107 bottles of 500-count, 20 mg Duloxetine Delayed-Release Capsules produced by Towa Pharmaceutical Europe and distributed nationwide.

It was initiated on October 10 and has been given a Class II designation, which means that the use of or exposure to the product “may cause temporary or medically reversible adverse health consequences,” according to the FDA.

The recalled lot was 220128, with a 12/2024 expiration date. 

Duloxetine is a medication used to treat depression, anxiety, and chronic pain, Jamie Alan, PhD, an associate professor of pharmacology and toxicology at Michigan State University, told Health. 

It is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors, or SNRIs. The drug works by increasing the amounts of serotonin and norepinephrine, substances in the brain that help maintain mental balance and stop the movement of pain signals.

If you take this medication, it’s understandable to have questions about what the recall means for your health. Here’s what you need to know.

What Is N-Nitroso-Duloxetine?

N-nitroso-duloxetine is an impurity found in duloxetine, Alan explained.  

“There is a concern that exposure to these nitrosamine-containing compounds will increase a person’s risk of cancer,” Alan said. “Ranitidine, used for acid reflux, was recalled a few years back for similar concerns.”

Nitrosamines are chemicals found in various foods, drinking water, cosmetics, and tobacco products, Kelly Johnson-Arbor, MD, a toxicologist at MedStar Health, told Health. 

“Although some nitrosamines are not associated with harmful health effects, human exposure to other nitrosamine compounds is associated with an increased risk of cancer, especially when people are exposed to these compounds in high doses and/or for a prolonged period,” Johnson-Arbor said.

The FDA notes that there are “multiple reasons” why nitrosamines like N-nitroso-duloxetine can end up in a medication. The source of nitrosamines can be related to the drug’s manufacturing process or chemical structure, as well as to the medications’ storage or packaging conditions.

The FDA is “working to determine the source of these impurities and will keep the public informed,” Towa Pharmaceutical Europe told Health in a statement. “At this time, Towa Pharmaceutical Europe is working with FDA and other regulators to implement the recall. As always, patient safety remains our top priority.”

What to Do If You Have the Recalled Medication

“Because this recall did not involve all formulations of duloxetine and only involved specific duloxetine products manufactured by a single manufacturer, readers should first determine if their prescription was included in the recall,” Johnson-Arbor said.

If your medication is part of the recall, the FDA recommends continuing to take it and contacting your doctor about potential alternative treatment options. Suddenly stopping duloxetine can cause a range of possible symptoms, including headache, vomiting, and the return of your symptoms.

“Don’t panic,” Alan said. “If you are taking this medication, call your healthcare provider. Do not abruptly stop the medication.”