Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Ireland Pharmaceuticals Unlimited Company | Ringaskiddy, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections |
| Pfizer Italia S.r.l. | Ascoli Piceno, Italy | Makes it and tests it | Problems found, fixed voluntarilyMar 14, 2025 · 5 inspections |
| Pfizer Ireland Pharmaceuticals Unlimited Company | Newbridge, Ireland | Tests it | Problems found, fixed voluntarilySep 23, 2022 · 8 inspections |
| Pfizer Manufacturing Deutschland GmbH | Freiburg im Breisgau, Germany | Packages it and labels it | Problems found, fixed voluntarilyJul 2, 2025 · 8 inspections |
Recalls
- Aug 13, 2021 · Class II · Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Lots: Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023 - Aug 13, 2021 · Class II · Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Lots: Lots 00018777, 00019289, 00019593, 00019682, 00019846, 00019977, 00020295, 00020448, 00020458, 00020480, 00021024, 00021073, 00021074, CW1565, CW1566, CW1567, CW1568, CW1569, CW1570, CW1571, CW1572, CW1573, CW1574, CW1575, CW1578, CW1579, CW1581, DF5277, DF5278, DF5279, DF5280, DF5281, DF5282, DR50… - Jun 9, 2021 · Class II · Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Lots: Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023 - Jun 9, 2021 · Class II · Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Lots: Lots 00020231, Exp 30 Sept 2021; 00020232, Exp 30 Nov 2021; 00020357, Exp 31 Dec 2021; 00020358, Exp 31, Jan 2022; 00020716, Exp 31, Jan 2022 ; ET1600, Exp 31, Jan 2023; ET1607, Exp 31, Jan 2023 & ET1609, Exp 31, Jan 2023. - Jun 9, 2021 · Class II · Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Lots: Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: EM1069 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: EC5911
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Varenicline: every company that makes it
- Form
- kit
- Strength
- 1 mg / 0.5 mg
- Approval
- NDA NDA021928
- On the market since
- May 10, 2006
- Package NDCs
0069-0471-030069-0471-28- Official label
- DailyMed (National Library of Medicine), updated Jan 23, 2026
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