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, Cherry 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: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.

Quantity: 304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 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.

Related Recalls

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