CHANTIX 0.5 miligram and 1 miligram Tablets
On September 16, 2021, Pfizer, the manufacturer of Chantix®, expanded their recall to include all lots of the drug.
This recall was issued due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. 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.