The U.S. Food and Drug Administration (FDA) has announced the recall of more than 7,100 bottles of the commonly prescribed antidepressant Duloxetine, sold under the brand name Cymbalta, due to the presence of a suspected cancer-causing chemical.
The voluntary recall was issued after tests revealed the toxic compound N-nitroso-duloxetine in the drug, which can pose health risks if present in high concentrations. Nitrosamines, including N-nitroso-duloxetine, can form during the production of pharmaceuticals. While low levels of these chemicals are sometimes found in medications, the FDA enforces strict limits on their concentration due to the potential long-term risk of cancer associated with prolonged exposure.
The recalled batch includes 7,107 bottles of 20mg Duloxetine Delayed-Release Capsules, sold in 500-count bottles under Lot number 220128 with an expiration date of December 2024.
The FDA advises consumers and healthcare providers to check their supplies and ensure that they are not using products from the affected lot. The agency also noted that nitrosamines can be linked to the drug’s manufacturing process, chemical structure, or storage conditions.
Consumers with the recalled product are encouraged to stop using it and consult their healthcare providers for further guidance.
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