Is Nicotine recalled?
18 FDA recalls mention Nicotine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nicotine.
Class III · Low risk Ongoing May 14, 2026
Reason Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…
Class III · Low risk Terminated Sep 9, 2020
Reason Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the…
Class III · Low risk Terminated Aug 19, 2014
Reason Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk Terminated Feb 20, 2014
Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling: Label Mixup:NICOTINE POLACRILEX, GUM, 2 mg may have potentially been mislabeled as one of the following drugs: FOLIC ACID, Tablet, 1 mg…
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as one of the following drugs: ESTRADIOL, Tablet…
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC…
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree…
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC…