Nicorette Lozenge — Class III drug recall D-1244-2014
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-1244-2014 |
|---|---|
| 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) |
| Quantity | 12,162 pallets |
| Reason classes | potency |
| Lot numbers | 12K16W |
Product
Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
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-1244-2014. 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.