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Chantix Distribution Pause

July 12, 2021

  • On June 24, 2021, multiple media outlets began reporting that Pfizer was suspending distribution of the smoking cessation aid, Chantix (varenicline), due to discovery of impurities that were found in some of the tablets during product testing.
  • Pfizer identified nitrosamine impurities in some lots of Chantix and halted supply “out of an abundance of caution.” Neither the FDA nor Pfizer have yet issued a recall notification.
  • Wholesalers are listing Chantix as backordered from the manufacturer with no expected date to resume shipping product.
  • The American Society of Health System Pharmacists (ASHP) and the FDA are listing Chantix on their Drug Shortage Lists.
  • Alternative aids for smoking cessation are available, including generic and non-prescription options (e.g., nicotine replacement therapies).
  • Members are encouraged to ask their health care providers about alternatives.
  • Generic formulations of Chantix are expected in 2021 but have not yet launched.
  • Per Optum’s usual process, if a formal recall is initiated by the manufacturer or by the FDA, Optum will send letters to impacted members.