Pfizer is voluntarily recalling the anti-smoking drug Chantix, a brand of varenicline, due to impurities that exceed approved levels, the Food and Drug Administration has announced.
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 that may have too much nitrosamine, N-nitroso-varenicline, based on the Acceptable Daily Intake (ADI) level established by Pfizer.
“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,” the FDA has said.
The FDA says there is no immediate risk to patients taking this medication, though long-term use “may be associated with a theoretical potential increased cancer risk in humans.” However, the FDA says the health benefits of quitting smoking outweigh the cancer risk from the impurity in varenicline.
Chantix helps smokers quit and is intended for short-term use. According to the FDA, cigarette smokers are 15 to 30 times more likely to get lung cancer than non-smokers.
The FDA said everyone is exposed to some level of nitrosamines, which are common in water and foods, including cured and grilled meats, dairy products and vegetables.
“These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the FDA said.
People taking Chantix should check with their doctor about whether they received an affected lot, and if appropriate, about alternative treatments. Pfizer has received no reports of “adverse events” related to this recall.
The FDA provided the following table that includes the national drug code (NDC), lot number, expiration date, and configuration details for Chantix tablets. The product lots were distributed across the U.S. and Puerto Rico from June 2019 to June 2021.
ProductNDCLot ExpDatePresentationConfig/CountChantix
(varenicline)
Tablets, 0.5 mg0069-0468-56000192132022 JANBottles56 tablets/bottleChantix
(varenicline)
Tablets, 0.5 mg0069-0468-56EC69942023 MAYBottles56 tablets/bottleChantix
(varenicline)
Tablets, 1 mg0069-0469-56EA60802023 MARBottles56 tablets/bottleChantix
(varenicline)
Tablets, 1 mg0069-0469-56EC98432023 MARBottles56 tablets/bottleChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03000202312021 SEPCartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tabletsChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03000202322021 NOVCartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tabletsChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03000203572021 DECCartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tabletsChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03000203582022 JANCartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tabletsChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03000207162022 JANCartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tabletsChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03ET160001/2023Cartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tabletsChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03ET160701/2023Cartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tabletsChantix
(varenicline)
Tablets, 0.5/1 mg0069-0471-03ET160901/2023Cartons containing 2 blister packsCarton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
For more information, go to the FDA website.