Chantix Recall Expanded After Pfizer Discovers More Lots Tainted With Carcinogen

Pfizer has expanded its recall of smoking cessation medication Chantix (Varenicline) to include a total of 12 lots that may contain unsafe levels of a nitrosamine, N-nitroso-varenicline — a carcinogen.  

The most recent additions to the Chantix recall include lots ET1600, EA6080, and EC9843 with expiration dates of either 1/2023 or 3/2023. The recall affects Chantix sold at the consumer level, according to Monday’s announcement by the Food and Drug Administration (FDA).  

“FDA reminds patients taking recalled varenicline to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition,” notes the agency in the updated Chantix recall notice. “The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.” 

On June 24, Pfizer issued the first recall. The drug maker announced on June 24 that it had discovered levels of N-nitrosodimethylamine — a known cancer-causing agent that is also known as NDMA — that are above an “acceptable” level of daily intake. 

“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product,” said the company in its first Chantix recall announcement. 

Consumers who take Chantix can check the FDA website for a complete list of recalled lots. Pfizer says that it has instructed wholesalers and distributors to stop using and quarantine the recalled lots and is setting up a way for consumers to return the recalled Chantix.  

This latest recall expansion is not the first time Chantix has been linked to adverse health effects. Since the drug was introduced, Chantix users have reported psychological side effects such as depression, aggression, homicidal tendencies, entertaining the thought of suicide, and even suicide attempts. 

Pfizer has faced a number of lawsuits by Chantix users and their family members who say that the drug caused severe depression and even resulted in suicide. Others have alleged that the drug caused severe psychological side effects, including blackouts that landed one Chantix user in jail.  

In 2009, the FDA placed a “black box” warning label on Chantix informing users that recent data showed the smoking cessation drug can cause depression, suicidal thoughts, attempted suicide, aggression and anger. 

Two years later, in June 2011, the FDA updated the Chantix side effects warning again to include heart attack and other severe cardiovascular events. 

Top Class Actions will continue to monitor the Chantix recall and keep readers updated with any developments.  

Have you used Chantix? Are you concerned about the recall? Tell us about it in the comment section below.

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