Bloomberg Law
Sept. 16, 2021, 2:28 PM

Pfizer Expands Carcinogen-Related Recall of Chantix to All Lots

Meghan Genovese
Meghan Genovese
Bloomberg News

Pfizer expands voluntary nationwide recall to include all lots of chantix (varenicline) tablets due to the presence of nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit, according to a statement issued today.

  • “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” Pfizer said in the statement, citing communications from the FDA
    • “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline,” Pfizer said
  • NOTE:
    • July 19, Pfizer issued nationwide voluntary recall ...