Pfizer is Recalling Chantix Due to N-Nitroso-Varenicline Contamination Cancer Risk
According to the FDA and an online news report posted on lynnwoodtimes.com, Pfizer is recalling all lots of Chantix 0.5 mg and 1 mg tablets at the consumer/patient level because of possible nitrosamine, N-nitroso-varenicline contamination. The recall announcement states that the amount of N-nitroso-varenicline detected was at or above the FDA’s acceptable limit.
The report states that long-term consumption of N-nitroso-varenicline may cause cancer in humans. However, the report states that there is “no immediate risk to patients” taking Chantix. According to the news article, the benefits of quitting smoking outweigh the potential cancer risk from nitrosamine impurity.
In July 202, Pfizer announced a recall of twelve specific lots of Chantix. This recall is expanding the recall to all lots prescribed to the public.
Consumers can review the Lot Numbers, NDCs, and Expiration Dates for the recalled Chantix tablets here.
The Chantix tablets were distributed throughout North America to wholesalers and distributors based in the United States, Puerto Rico, and U.S. Virgin Islands from May 2019 until September 2021. The report states that Pfizer has contacted their direct consignees to arrange the return of any recalled product. Distributors and wholesalers with an existing inventory of Chantix are asked to halt the distribution of the tablets and to immediately quarantine the product.
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