Nicotine polacrilex lozenge — Class III drug recall D-1242-2014
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-1242-2014 |
|---|---|
| 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 | 00135-0510-03, 00135-0510-05 |
| Lot numbers | 12H17N, 13727 |
Product
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
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-1242-2014. 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.