Nicorette — Class III drug recall D-1245-2014
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-1245-2014 |
|---|---|
| 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 | 00125-0508-03, 00135-0508, 00135-0508-02, 00135-0508-03, 00135-0508-04, 00135-0509, 00135-0509-02, 00135-0509-03, 00135-0509-04 |
| Lot numbers | 12J08N, 13374, 13444, 14190 |
Product
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
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-1245-2014. 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.