Nicotine Polacrilex Lozenge 4mg (GlaxoSmithKline) – Specification Failure (2014)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot R
Brand
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Lot Codes / Batch Numbers
Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15), 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial, Lot # 13924 (exp 12/14), 13975 (exp 12/14), 14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14).
Products Sold
Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14).
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline is recalling Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 coun due to Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026