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Anti-Smoking Drug, Chantix, Recalled After Discovery of High Levels of Carcinogens

— July 20, 2021

Pfizer recently announced a recall for certain Chantix tablets over contamination concerns.

Earlier this week, Pfizer issued a voluntary recall of its popular anti-smoking drug, Chantix, over concerns that it may contain impurities that exceed approved levels, according to the Food and Drug Administration. At the moment, the recall includes “two lots of Chantix 0.5 mg tablets, two lots of Chantix 1 mg tablets, and eight lots of a Chantix kit of 0.5mg/1 mg tablets.” 

Recalled Chantix tablets
Recalled Chantix tablets; image courtesy of the FDA,

The recall states that the tablets may contain “too much nitrosamine, N-nitroso-varenicline, based on the Acceptable Daily Intake (ADI) level established by Pfizer.” As part of the notice, the FDA stated:

“N-Nitroso-varenicline belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens (substances that could cause cancer), based on laboratory tests such as rodent carcinogenicity studies.”

Fortunately, the FDA said there is no immediate risk if patients take the medication. However, long-term use could pose issues. For example, long-term use “may be associated with a theoretical potential increased cancer risk in humans.” The agency said, “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

For those who don’t know, Chantix is a drug designed to help people quit smoking. It’s meant for short-term use, and has been a life-saving drug for many, considering the FDA claims “cigarette smokers are 15 to 30 times more likely to get lung cancer than non-smokers.”

For now, patients taking Chantix should consult with their doctor to see if their tablets are affected by the recall. At the moment, the following tablets are included in the recall.


Pfizer recalling popular stop-smoking drug Chantix

Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

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