On July 19, the FDA and Pfizer announced a Chantix® recall due to a cancer-causing chemical in the smoking-cessation medication.
The impurity is N-nitroso-varenicline, which is a type of chemical known as a nitrosamine. It is believed to cause cancer in humans.
Pfizer did not report any injuries linked to the recalled medication.
Instead, Pfizer insisted that the “health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine.”
“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,” according to recall.
The 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. The full list of NDCs, lot numbers and expiration dates are in the recall notice.
Last month, Pfizer stopped distributing Chantix and issued a recall in Canada due to nitrosamines — but not in the United States, until now.
Chantix is now one of many drugs that have been recalled due to nitrosamine impurities, including drugs for diabetes (metformin), heartburn (Zantac®), high blood pressure (valsartan), and more.