Product: 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.
Reason for recall: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Recall initiated: 20210813
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated