Varenicline recalls

The FDA has published 8 recalls involving Varenicline since 2021. The latest was reported on 17 Dec 2025. Most were for nitrosamine impurity. Pfizer has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2021

Last 12 months1reported

Class I00% of total

Ongoing6latest 17 Dec 2025

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 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 88%Class III 1 13%

Why varenicline is recalled

Companies

Brands

Chantix788%
Varenicline Tartrate113%

By year

2025113%
2021788%

Ongoing varenicline recalls

6 active

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS III	Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
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 varenicline recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS III	Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
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

Should you stop taking Varenicline?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.