Chantix Recall Expanded To U.S. Products Due To N-Nitroso Varenicline Contamination

Following a recent announcement that Pfizer would halt production of the stop-smoking drug Chantix, due to the presence of potentially cancer-causing chemicals, the manufacturer has announced a recall for 12 lots of the drug sold in the United States.

The FDA announced the Chantix recall on July 19, indicating batches of the drug contain levels of a chemical known as N-nitroso-varenicline at amounts which exceed an Acceptable Daily Intake (ADI) level set by Pfizer itself. While unverified, it is believed the chemical is a cancer risk to humans.

Chantix (varenicline) is a prescription medication introduced by Pfizer in 2006, designed to help people quit smoking. However, less than three years after its release, the FDA required Pfizer to add a “black box” warning, following a number of reports involving suicide and other unusual behavior among users. The FDA rescinded the label requirement and removed the warning in December 2016.

The recall comes after the manufacturer announced it was halting Chantix distribution in June, when the drug became the latest linked to a class of cancer-causing chemicals known as nitrosamines. It announced a recall in Canada at the time, but not one in the United States.

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, and the FDA is not calling on users to stop taking the drug.

“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,” Pfizer said in the recall announcement. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

The recall for Chantix affects two lots of 0.5 mg Tablets, two lots of 1 mg Tablets, and eight lots of a Chantix kit of 0.5/1 mg Tablets. A complete list of NDCs, lot numbers and expiration dates are included in the recall notice.

Pfizer has instructed wholesalers and distributors to stop use and distribution of these products and quarantine them immediately. They, and patients, have been instructed to contact Stericycle at 888-276-6166 for information on how to return the product and obtain a reimbursement.

Those who received free Chantix through the Pfizer Patient Assistance Protram (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP) have been instructed to request replacement product by calling 833-203-2776.