CLASS II ONGOING Drug recall · Reported 11 Aug 2021 · FDA Enforcement Report
Chantix (varenicline) tablets, 1 mg recalled by Pfizer
Pfizer is recalling Chantix (varenicline) tablets, 1 mg, distributed nationwide in the US. The recall was initiated on 9 Jun 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0701-2021
- FDA event ID
- 88077
- Recalling firm
- Pfizer, New York, NY
- Brand
- Chantix
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jun 2021
- FDA classified
- 30 Jul 2021
- Reported
- 11 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 9 Jun 2021 | Recall initiated by company | |
| 30 Jul 2021 | Classified by FDA | +51 days |
| 11 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
Where it was distributed
Nationwide
Questions about this recall
Is Chantix (varenicline) tablets, 1 mg recalled?
Yes. Pfizer recalled Chantix (varenicline) tablets, 1 mg on 9 Jun 2021. The recall is Class II and its status is Ongoing. Recall number D-0701-2021.
Why was it recalled?
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Which lots are affected?
Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Varenicline recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Chantix (varenicline) tablets 1 mg recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chantix (varenicline) tablets 5mg recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chantix (varenicline)Tablets, Contains recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chantix (varenicline) tablets, 5mg* recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |