In July 2021, Pfizer voluntarily recalled several lots of their smoking cessation drug, Chantix. Higher than acceptable levels of an impurity were found in the medication. The impurity, N-nitroso-varenicline, may cause cancer.
Since July, Pfizer has expanded the recall several times. The most recent was in September 2021. It includes Chantix 0.5 mg and 1 mg tablets from the US market.
Voluntary drug recalls occur when there’s an agreement between the drug maker or distributor and the Food and Drug Administration (FDA). Together they decide to remove a drug from the market. Voluntary drug recalls allow for a period of investigation into the defect. Sometimes this leads to a correction of the defect.
The FDA has reminded patients that the health benefits of stopping smoking outweigh the cancer risk from the impurity in Chantix. The FDA has also advised patients to contact their pharmacist or prescriber before stopping the medication.
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