FDA Drug recall D-0810-2021
Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc
- FDA Drug
- Class II
- ongoing
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc by Pfizer, citing CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0810-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-13 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
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
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Identifiers
| ndc | 0069-0468-56 |
|---|---|
| ndc | 0069-0469-56 |
| ndc | 0069-0469-28 |
| ndc | 0069-0471-03 |
| ndc | 0069-0471-28 |
| code_info | Lots 00018777, 00019289, 00019593, 00019682, 00019846, 00019977, 00020295, 00020448, 00020458, 00020480, 00021024, 0002…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, DR5086, DR5092, DR5093, DR5094, DT3885, DW4148, DW4152, DY7987, EC9841, EC9842, EC9847, EC9848, EE1011, EM1069, EM1070, EN5694, EN5695, EP1717, EP1718, EP1719, EW2012, EW3854, EW3865, EX2102, EX2103 EXPIRATION DATE: September 2021 December 2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0810-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.