Pfizer issues voluntary recall of Chantix

Due to contamination with possible carcinogens, this smoking cessation product is not currently available as a brand-name drug

By Jennifer Larson | Updated on Oct. 4, 2023 Medically reviewed by Karen Berger, Pharm.D.

In July 2021, Pfizer announced a voluntary recall of nine lots of Chantix (varenicline), its smoking cessation drug, due to concern about levels of nitrosamine in this medication. Nitrosamines are a type of impurity that can exist in pharmaceutical products and are considered possible carcinogens when they are above acceptable levels.

Varenicline, the first generic version of Chantix, was approved by the U.S. Food and Drug Administration on August 11, 2021, one month after Pfizer’s initial recall. In September 2021, Pfizer expanded the recall to all lots of 0.5 mg and 1 mg tablets of Chantix. Currently, Chantix is not available as a brand-name drug (Pfizer still has production paused) and only varenicline is available as the generic.

Why was Chantix recalled?

You’ve been exposed to nitrosamines many times and probably didn’t even know it. That’s because these compounds are common in water and foods, including cured and grilled meats, dairy products and vegetables, according to the FDA. At low levels, experts don’t believe they’re harmful.

However, nitrosamine impurities could potentially increase your cancer risk if you consume enough over an extended period of time. As such, the FDA set limits for the daily intake of nitrosamines. Nitrosamine impurities have led to the recall of other medications, such as Zantac (ranitidine) and metformin ER.

After previous recalls, the FDA created guidance for pharmaceutical manufacturers to detect and prevent higher-than-recommended nitrosamine levels. As part of the suggested investigation, Pfizer discovered levels of the impurity known as N-nitroso-varenicline that exceeded the acceptable intake limit in Chantix. That prompted Pfizer’s decision to voluntarily recall certain lots of this particular drug.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

What to take instead of Chantix

The generic varenicline is available in doses of 0.5 mg (white pill) and 1.0 mg (blue pill) for use as an aid in smoking cessation treatment. It works by blocking the pleasant effects of nicotine on the brain.

There are three ways to take varenicline, and a healthcare professional will help you determine the best method before beginning the medication.

Method one: Choose a date when you will quit smoking, and begin taking the medication one week prior to your quit date. You can continue to smoke until your quit date.
Method two: Start treatment with varenicline before choosing your quit date. Your quit date may be anywhere from eight to 35 days after you begin the medication, and you can smoke until the scheduled date.
Method three: Start taking varenicline and stop smoking slowly during treatment, with a goal of smoking half your normal amount weeks one to four, one quarter of your starting amount weeks five to eight, and as few cigarettes as possible weeks nine to 12 until you’re no longer smoking.

You should take varenicline with a full glass of water or food to reduce the odds of experiencing nausea, a common side effect. Most people take varenicline for 12 weeks, beginning with at a lower dose to get used to the medication:

Days 1-3: One 0.5 mg pill each morning
Days 4-7: Two 0.5 pills (one in the morning and one in the evening)
Day 8 through the completion of treatment: Two 1.0 mg pills (one in the morning and one in the evening)

If you have any questions about the Chantix recall or varenicline dosages, you can speak with your healthcare provider or pharmacist.