Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Is Varenicline recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Varenicline (12 total). Check the affected lots below.
Most common reason: Nitrosamine impurity (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Varenicline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Varenicline recalls on record
none so far in 2026; 12 on record, newest first
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Varenicline
Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.
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