Chantix — Class II drug recall D-0810-2021
Ongoing recall by Pfizer Inc., reported 2021-09-29, distributed nationwide. CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable inta
| Recall number | D-0810-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-09-17 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 00069-0468, 00069-0468-56, 00069-0469, 00069-0469-28, 00069-0469-56, 00069-0471, 00069-0471-03, 00069-0471-28 |
| Lot numbers | 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, DR5086, DR5092, DR5093, DR5094, DT3885, DW4148, DW4152 and 18 more |
| Expiration dates | 2021-09-20 |
Product
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.
Reason for recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0810-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.