Pfizer is voluntarily recalling 4 additional lots of its smoking cessation therapy Chantix (varenicline) 0.5mg/1mg tablets due to the presence of a nitrosamine impurity above the Food and Drug Administration (FDA)’s acceptable daily intake limit. 

The 4 additional recalled lots of Chantix (varenicline) 0.5/1mg; NDC Number 0069-0471-03, include the following:

  • Lot Number 00018522; Expiration Date August 2021
  • Lot Number 00018523; Expiration Date August 2021
  • Lot Number 00018739; Expiration Date August 2021
  • Lot Number 00018740; Expiration Date August 2021

The full list of recalled lots of Chantix can be found here and were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from June 2019 to June 2021.

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


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Adverse events associated with these products should be reported to the FDA’s MedWatch Program.

In July 2021, the FDA announced that it would permit varenicline tablets containing N-nitroso-varenicline up to the interim acceptable intake limit of 185ng per day to be distributed in the US in order to maintain an adequate supply of the smoking cessation therapy in the country. The Agency noted that the health benefits of smoking cessation continue to outweigh the cancer risks from the nitrosamine impurity.

Reference

Pfizer expands voluntary nationwide recall to include four additional lots of Chantix® (varenicline) tablets due to N- nitroso varenicline content. News release. US Food and Drug Administration. Accessed August 19, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-four-additional-lots-chantixr-varenicline-tablets