Nicorette Lozenges Mini (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
Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.
Brand
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Lot Codes / Batch Numbers
(20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15), (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15)
Products Sold
(20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15)
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline is recalling Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vial 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