Chantix recalls

Chantix products have been recalled 7 times, most recently on 29 Sep 2021. The recalling company is usually Pfizer. The most common reason is nitrosamine impurity.

Total recalls7since 2021

Last 12 months0reported

Class I00% of total

Ongoing5latest 29 Sep 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 100%Class III 0 0%

Why chantix is recalled

Nitrosamine Impurity571%
Manufacturing (CGMP) Deviations229%

Companies

Pfizer571%
Cardinal Health229%

By year

20217100%

Ongoing chantix recalls

5 active

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021Drug	CLASS II	Chantix (varenicline) tablets 1 mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
29 Sep 2021Drug	CLASS II	Chantix (varenicline) tablets 5mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
11 Aug 2021Drug	CLASS II	Chantix (varenicline)Tablets, Contains recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
11 Aug 2021Drug	CLASS II	Chantix (varenicline) tablets, 1 mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
11 Aug 2021Drug	CLASS II	Chantix (varenicline) tablets, 5mg* recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide

All chantix recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021Drug	CLASS II	Chantix (varenicline) tablets 1 mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
29 Sep 2021Drug	CLASS II	Chantix (varenicline) tablets 5mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
11 Aug 2021Drug	CLASS II	Chantix (varenicline)Tablets, Contains recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
11 Aug 2021Drug	CLASS II	Chantix (varenicline) tablets, 1 mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
11 Aug 2021Drug	CLASS II	Chantix (varenicline) tablets, 5mg* recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
2 Jun 2021Drug	CLASS II	Chantix (varenicline) Tablets Continuing Month Box Contains recalledChantix	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
2 Jun 2021Drug	CLASS II	Chantix (varenicline) Tablets Starting Pack Contains recalledChantix	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.