Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Nicotine polacrilex lozenge Recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline Due to Failed Lozenge Specifications; Lozenges are overly thick, overly...

Date: February 20, 2014
Company: GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline directly.

Affected Products

Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.

Quantity: 146,424 81 Ct. Vials, 105,091 189 Ct Vials

Why Was This Recalled?

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline has 10 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report