September 2, 2021
Pfizer has recalled an additional four lots of Chantix® (varenicline) after identifying a nitrosamine impurity, N-nitroso-varenicline, above the manufacturer’s established acceptable daily intake level. Nitrosamines may increase the risk of cancer, though Pfizer and the U.S. FDA have stated there is no immediate risk to the health of individuals taking the recalled medication.
Chantix is FDA approved for short-term use to assist in smoking cessation. The recall notice advises patients currently taking Chantix to consult with their healthcare provider to determine if they have received an affected lot and if an alternative treatment option is appropriate. For instructions on how to return the product and obtain reimbursement, patients should contact Stericycle at 1-888-276-6166.
Healthcare providers can contact Pfizer with questions about the recall at 1-800-438-1985, option 3, and report adverse events and product complaints to Pfizer at 1-800-438-1985, option 1. Adverse events can also be reported to the FDA’s MedWatch program. As of Pfizer’s announcement of the additional four recalled lots, no adverse events have been reported in association with use of the affected medication.
A full copy of the recall notice, including a table of all Chantix lots currently recalled in the United States, can be found on the FDA’s website.
There is no impact to members through Benecard Central Fill from the additional four recalled lots.