Nicotine polacrilex lozenge — Class III drug recall D-1239-2014

Terminated recall by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline, reported 2014-04-30, distributed nationwide. Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Recall number	`D-1239-2014`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline, Aiken, SC, United States
Recall initiated	2014-02-20
Classified	2014-04-18
Reported by FDA	2014-04-30
Terminated	2017-01-20
Distributed	Nationwide (US)
Reason classes	potency
NDC	`00135-0513-01`, `00135-0513-02`, `00135-0513-03`, `00363-9200-01`, `30142-0664-01`
Lot numbers	`13481`, `13643`, `13671`, `13855`, `14041`

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1239-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.