Pfizer Recalling All Chantix Batches Due to Carcinogen in Smoking Cessation Drug

Following the discovery of cancer causing chemicals in Chantix, Pfizer has once again expanded the recall to now include all batches of the stop-smoking drug distributed nationwide.

Chantix (varenicline) is a prescription medication introduced by Pfizer in 2006, to help people quit smoking. However, the drug has been plagued by problems this year, after high levels of the chemical byproduct N-nitroso-varenicline has been found in pills, leading to a series of Chantix recalls issued over the past few months.

In June 2021, Pfizer first disclosed the Chantix problems, after halting distribution for the drug and recalling one lot in Canada. Weeks later, the Chantix recall was expanded to include 12 batches of the medication sold in the United States in July 2021, and the drug maker announced that it was recalling another four lots of Chantix in August 2021.

This week, Pfizer issued a press release indicating a complete Chantix recall is now being issued for all lots of both its 0.5 mg and 1 mg tablets, all due to the same problem first discovered in June 2021, with high levels of the cancer-causing chemicals in certain pills, at levels higher than deemed acceptable by the FDA.

The drug maker is now recalling Chantix pills distributed throughout the U.S., U.S. Virgin Islands, and Puerto Rico from May 2019 to September 2021.

“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” the press release states. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

Over the last few years, several drugs, such as Zantac, valsartan and metformin, have faced similar recalls, primarily to do the presence of a nitrosamine known as N-Nitrosodimethylamine (NDMA). Pfizer indicates it has received no reports of adverse events linked to this recall, but exposure to the chemicals in other pills has been linked to reports of cancer as the chemicals move through the body. At this time, the FDA is not calling on users to stop taking the drug.

The company is recommending all suppliers and wholesalers check their inventories for any remaining supplies and stop distributing them immediately.

Pfizer and the FDA recommend patients taking the drug consult with their health care provider immediately to determine if alternative treatments are available. Smoking is still considered a much higher cancer risk than the recalled tablets.

Consumers with questions can call 800-438-1985 or visit www.pfizermedinfo.com.