Drug Safety Alerts

Chantix® Tablets Consumer-Level Recall

7/19/2021

On July 19, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Chantix® 0.5 mg tablets, Chantix® 1 mg tablets, and Chantix® kit of 0.5 mg/1 mg tablets, manufactured by Pfizer. This recall was issued due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

A complete list of the affected products and lot numbers can be found here.

According to Pfizer, 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. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

The FDA recommends that patients taking recalled Chantix® continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in Chantix®.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Chantix® 0.5 mg tablets, Chantix® 1 mg tablets, and Chantix® kit of 0.5 mg/1 mg tablets to contact their prescriber.

For more information, please call Pfizer Medical Information at 1-800-438-1985, Monday through Friday, 9:00 am to 5:00 pm (ET) or visit www.pfizermedinfo.com. You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov.