FDA recalls over 7,000 bottles of antidepressant due to possible cancerous chemical

 The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can potentially cause cancer.

The recall went into effect on Oct. 10. More than 7,100 bottles of the medication have been recalled.

Here’s everything you need to know.

Why is there a duloxetine recall?

The FDA says there is the “presence of nitrosamine drug substance related impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognized acceptable daily intake limits for nitrosamines. Nitrosamines below this level are acceptable in drugs,” the FDA says on its website. “If drugs contain levels of nitrosamines above the acceptable daily intake limit, FDA recommends these drugs be recalled by the manufacturer.”

“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” the agency adds, “but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.” 

What kind of recall is this?

The FDA is calling this a Class II recall. That is considered “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA.

What is being recalled?

The recall is lot No. 220128, with an expiration date of December 2024.

What should you do if you have pills that have been recalled?

The FDA recommends on its website contacting your pharmacy to confirm if your medicine is indeed part of a recall. If it was, you can speak to your pharmacist to figure out what to do and whether you should look for an alternative medication.

“The FDA encourages patients to talk to their health care professional if they have questions about their medicine, as the risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines. The FDA and the international scientific community do not expect nitrosamines to cause harm when ingested at low levels,” the agency says.