Pfizer is voluntarily recalling several lots of Chantix (varenicline) 0.5 mg and 1 mg tablets because they were found to contain levels of N-nitroso-varenicline, a nitrosamine impurity, above the FDA's acceptable intake limit. This medication is used to help adults quit smoking and is distributed nationwide in various package sizes including 56-count bottles and blister packs. While no adverse events related to this specific impurity have been reported to date, Pfizer is recalling these specific lots as a precautionary measure to ensure consumer safety.
Long-term exposure to N-nitroso-varenicline above acceptable levels may increase the risk of cancer. This impurity belongs to a class of substances that are common in water and foods but are regulated in medications to prevent health risks from prolonged consumption.
Refund and pharmaceutical guidance
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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