Update: Replacement for CHANTIX® Smoking Cessation Product Recall

Sept. 7, 2021

Updated Sept. 27, 2021

Update: On Sept. 16, 2021, Pfizer expanded its voluntary recall of Chantix to include all lots of 0.5 mg and 1 mg tablets. We will notify affected members. You may also receive a notification.

Drug manufacturer Pfizer has issued a voluntary recall of its CHANTIX smoking cessation product. To help alleviate a shortage of these products, Blue Cross and Blue Shield of Texas (BCBSTX) is temporarily covering Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets. The coverage was effective as of Aug. 10, 2021. It does not apply to members in our Texas Medicaid or Medicare Advantage plans.

About the Chantix recall: The recall was due to higher than acceptable levels of N-nitroso-varenicline, an impurity that may be linked to an increased risk of cancer. Learn more from the U.S. Food and Drug Administration (FDA).

What this means for you: Consider contacting our members who may be taking CHANTIX to discuss other treatment options. Our members may also be alerted to this recall notice by their pharmacy.

The FDA advises individuals taking the recalled Chantix to continue to do so until their doctor, health care professional or pharmacist provides a replacement. No immediate risk to those taking CHANTIX has been found because it’s meant for short-term use. The health benefits of stopping smoking outweigh the cancer risk from the impurity, according to the FDA.

Benefits and coverage: Members' cost share for Apo-Varenicline is based on their benefit plan and is the same as their cost share for Chantix. Some members’ plans also have coverage under a preventive health benefit, which offers lower or no cost share to encourage adherence.

If you have questions about a member’s pharmacy benefits, call the number on the member’s ID card.


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This material is for informational purposes only and is not a substitute for the independent medical judgment of a physician or other health care provider. Physicians and other health care providers are encouraged to use their own medical judgment based upon all available information and the condition of the patient in determining the appropriate course of treatment. The fact that a service or treatment is described in this material is not a guarantee that the service or treatment is a covered benefit and members should refer to their certificate of coverage for more details, including benefits, limitations and exclusions. Regardless of benefits, the final decision about any service or treatment is between the member and their health care provider. References to third party sources or organizations are not a representation, warranty or endorsement of such organizations. Any questions regarding those organizations should be addressed to them directly.