Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chantix (varenicline)Tablets 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, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
Quantity: 350,985 cartons
Why Was This Recalled?
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs 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