CLASS II ONGOING Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report

Chantix (varenicline) tablets 0.5mg/1mg recalled by Pfizer

Pfizer is recalling Chantix (varenicline) tablets 0.5mg/1mg, distributed nationwide in the US. The recall was initiated on 13 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611 EXPIRATION DATE: August 2021 January 2023

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-0808-2021
FDA event ID: 88497
Recalling firm: Pfizer, New York, NY
Classification: Class II
Status: Ongoing
Recall initiated: 13 Aug 2021
FDA classified: 17 Sep 2021
Reported: 29 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Nitrosamine Impurity

Timeline

13 Aug 2021	Recall initiated by company
17 Sep 2021	Classified by FDA	+35 days
29 Sep 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 FDA s 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 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.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Which lots are affected?

Lots 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611 EXPIRATION DATE: August 2021 January 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 88497

This product is part of a recall event; the main page for the event is Chantix (varenicline) tablets 0.5mg recalled by Pfizer.

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021	CLASS II	Chantix (varenicline) tablets 0.5mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide
29 Sep 2021	CLASS II	Chantix (varenicline) tablets 1 mg, Carton recalled by Pfizer	Pfizer	Nitrosamine Impurity	Nationwide
29 Sep 2021	CLASS II	Chantix (varenicline) tablets 1 mg recalled by PfizerChantix	Pfizer	Nitrosamine Impurity	Nationwide

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Other Chantix (varenicline recalls

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Reported	Class	Recall	Company	Reason	Where
29 Sep 2021Drug	CLASS II	Chantix (varenicline) tablets 1 mg, Carton recalled by Pfizer	Pfizer	Nitrosamine Impurity	Nationwide