Antidepressant recalled after tests find elevated levels of a cancer-causing compound

A recall involving bottles of duloxetine has been issued across the United States after testing identified higher-than-recommended amounts of a cancer-linked impurity.

What's happening?

Breckenridge Pharmaceuticals, based in New Jersey, has announced a recall of some duloxetine delayed-release capsules. The drug is the generic form of Cymbalta and is commonly used to treat depression, anxiety, and fibromyalgia, NBC New York reported.

According to the U.S. Food and Drug Administration, testing found that the capsules contained N-nitroso-duloxetine at levels above the agency's recommended threshold. This type of nitrosamine impurity can arise during a drug's manufacturing, storage, or packaging, and long-term exposure above acceptable limits may raise cancer risks.

Among the products covered by the recall are 30-milligram capsules bearing lot code 241180C and an expiration date of April 2027, the FDA said. A separate notice from the California Board of Pharmacy noted that Breckenridge is also recalling two lots of 60-milligram capsules, according to NBC.

The recalled products were shipped nationwide.

Why is this concerning?

Duloxetine is not a medication that many patients can simply stop taking on their own.

The drug is used to treat serious mental health conditions and chronic pain, and interrupting treatment may be stressful and potentially harmful if handled incorrectly.

Because stopping some antidepressants abruptly can cause withdrawal-like effects or allow symptoms to return, health officials say patients should continue taking the medication until they have spoken with a doctor.

What can I do?

If you have duloxetine at home, the first step is to check the bottle label for the dosage, lot code, and expiration date.

Anyone whose medication matches the recalled information should contact their pharmacist or prescribing doctor to discuss next steps, including replacement options.

Patients are being told not to discard the medicine or stop taking it unless a medical professional advises them to do so. A doctor or pharmacist can help confirm whether a prescription is included in the recall and explain what to do if so.

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