FDA Recalls Thousands of Bottles of Popular Antidepressant Cymbalta (Duloxetine)

The U.S. Food and Drug Administration has recalled more than 7,000 bottles of duloxetine—an antidepressant sold under the brand name Cymbalta that’s often prescribed to treat chronic pain. The Class II recall was initiated due to the medication containing levels of N-nitroso-duloxetine, a chemical that can be toxic if consumed at certain levels.

N-nitroso-duloxetine is part of a group of chemicals known as nitrosamines that are commonly found in food and water products. At high levels, and with prolonged exposure, the chemical has the potential to cause cancer, according to multiple studies, which is why its limit is strictly regulated by the FDA.

Why were nitrosamines present?

“There are multiple reasons why nitrosamines can be present in drugs. FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the FDA said in a statement to Newsweek about the Class II recall. “As foods and drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.”

Class II recalls are the second most serious of the FDA recall classification system (Class I being the most serious and Class III being the least). It indicates that recalled products have the potential to trigger “temporary or medically reversible adverse health consequences,” according to the FDA.

Are all duloxetine bottles being recalled?

No. This recall pertains specifically to the 20mg Duloxetine Delayed-Release Capsules, packaged in 500-count bottles. The lot number for the affected products is 220128, and they have an expiration date of 12/2024. A total of 7,104 bottles are included in the recall.

Duloxetine, or Cymbalta, belongs to a class of medications known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). They work by increasing the activity of serotonin and norepinephrine, both of which are known to play a role in regulating mood and pain.

These medications are used to treat depression, anxiety and sometimes nerve pain. Although SSNRIs are typically taken daily, it can take several weeks before their therapeutic effects are noticeable. Similarly, it is recommended that anyone wanting to stop taking an SSNRI do so gradually over a period of 2 to 4 weeks, as quitting cold turkey without phasing the doses out could lead to withdrawal symptoms like dizziness, nausea and headaches.

What to do if your medication is affected

Because of the withdrawal symptoms associated with SSNRIs, the FDA is recommending that anyone taking the batch of medications included in the recall consult with their provider about next steps, rather than stop taking the medication immediately.