Pfizer Inc. is voluntarily recalling approximately 1,106,613 units of Chantix (varenicline) tablets, a prescription medication used to help people stop smoking. The recall was initiated because certain lots of the tablets contain a nitrosamine impurity called N-nitroso-varenicline at levels that exceed the FDA's interim acceptable intake limits. These products were distributed nationwide across the United States and were manufactured in Ireland.
Long-term exposure to N-nitroso-varenicline above acceptable limits may be associated with a potential increased risk of cancer in humans. While everyone is exposed to some level of nitrosamines in common foods and water, high levels of this specific impurity over time pose a long-term health risk.
Refund for unused medication.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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