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N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.

The recalled lots of Chantix were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from May 2019 to September 2021.

To date, the Company has not received any reports of adverse events related to this recall.

Long-term use of a product containing N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.