Pfizer is recalling 9 lots of its smoking cessation therapy Chantix (varenicline) as it may contain levels of a nitrosamine impurity above the Food and Drug Administration (FDA)’s acceptable daily intake limit. 

The 9 recalled lots of Chantix (varenicline) include:

  • Lot Number 00020231; Expiration Date 9/30/2021
  • Lot Number 00020232; Expiration Date 11/30/2021
  • Lot Number 00020357; Expiration Date 12/31/2021
  • Lot Number 00020358; Expiration Date 1/31/2022
  • Lot Number 00020716; Expiration Date 1/31/2022
  • Lot Number 00019213; Expiration Date 1/31/2022
  • Lot Number ET1607; Expiration Date 1/31/2023
  • Lot Number ET1609; Expiration Date 1/31/2023
  • Lot Number EC6994; Expiration Date 5/31/2023

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. Pfizer will not be releasing Chantix into the US market until the N-nitroso-varenicline levels have been confirmed to be below what is considered acceptable. The FDA is recommending that health care professionals quarantine product samples and consider other available treatment options for their patients while the investigation continues.

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


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Reference

FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level. [press release]. Silver Spring, MD: US Food and Drug Administration; July 2, 2021.