Pfizer recalled several lots of the anti-smoking drug Chantix after tests found high levels of a chemical impurity that can cause cancer.
UPDATE: Chantix Recalled for Cancer Risk
On July 19, 2021, Pfizer recalled Chantix® due to a cancer-causing chemical impurity called N-nitroso-varenicline, also known as a “nitrosamine.” It is believed to cause cancer in people, although Pfizer did not report any injuries in the recall notice.
What is the Risk?
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.”
List of Recalled Chantix Medications
The list of recalled Chantix medications include:
- 56-count bottles of Chantix 0.5-mg tablets with Lot #00019213 and expiration date January 2022
- 56-count bottles of Chantix 0.5-mg tablets with Lot #EC6994 and expiration date May 2023
- 56-count bottles of Chantix 1-mg tablets with Lot #EA6080 and expiration date March 2023
- 56-count bottles of Chantix 1-mg tablets with Lot #EC9843 and expiration date March 2023.
The recall also involves 8 lots of Chantix cartons containing one blister pack of 0.5 mg tablets and one blister pack of 1 mg tablets, including Lot #00020231, Lot #00020232, Lot #00020357, Lot #00020358, Lot #00020716, Lot #ET1600, Lot #ET1607, and Lot #ET1609.
Chantix Class Action Lawsuit Information
In July 2013, settlement agreements were finalized in nearly 700 Chantix lawsuits — the first step in resolving over 3,000 lawsuits pending in federal court in the Northern District of Alabama. As of April 2014, only about 250 lawsuits remained.
Plaintiffs allege that Chantix causes a variety of psychological problems, including suicidal behavior, and other severe side effects. In a report with the Securities and Exchange Commission (SEC), Pfizer said it had agreed to settle roughly 80% of the lawsuits for $273 million, and they have set aside $15 million to resolve the rest.