Nicotine polacrilex lozenge — Class III drug recall D-1241-2014
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-1241-2014 |
|---|---|
| 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 | 00135-0510, 00135-0510-01, 00135-0510-06, 00135-0510-07, 00135-0511, 00135-0511-01, 00135-0511-06, 00135-0511-07, 00135-0514-03, 00363-0208-07, 30142-0861-01 |
| Lot numbers | 13404, 13417, 13449, 13656 |
Product
Nicotine polacrilex lozenge, 2 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: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.
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-1241-2014. 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.