Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chantix (varenicline) tablets 0.5mg/1mg Recalled by Pfizer Inc. Due to CGMP Deviations: Presence of the N-nitroso-varenicline impurity above...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pfizer Inc. directly.
Affected Products
Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
Why Was This Recalled?
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pfizer Inc.
Pfizer Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report