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September 16, 2021 – Pfizer is now recalling all lots of Chantix® (varenicline) 0.5mg and 1mg tablets in the United States due to excess levels of a nitrosamine called N-nitroso-varenicline. Chantix is used as an aid in quitting smoking.
- There is no impact to members through Benecard Central Fill.
- In recent months, Pfizer has issued smaller recall announcements for select lots of Chantix due to the presence of N-nitroso-varenicline above acceptable levels.
- N-nitroso-varenicline may cause cancer following sufficient exposure. However, Pfizer and the U.S. FDA have stated there is no immediate risk to patients who are taking Chantix, and that the health benefits of smoking cessation outweigh the potential risks of nitrosamine exposure.
- According to Pfizer, patients who are currently taking Chantix should contact their healthcare provider to determine if alternate treatments are available.
- Treatment alternatives are available in the form of a generic from Par Pharmaceuticals (launched in August 2021 following FDA approval) and Apotex-manufactured varenicline imported from Canada with the FDA's permission to address a varenicline shortage.
- Pfizer has provided the following points of contact for questions about the recall:
- Patients in Possession of Chantix Tablets: Contact Stericycle at 1-888-276-6166 for return instructions and to obtain reimbursement.
- Healthcare Professionals: Call 1-800-438-1985 (option 3) or visit pfizermedinfo.com for medical questions and call 1-800-438-1985 (option 1) to report adverse events and product complaints.
- A full copy of the recall announcement is available on the FDA's website.