FDA Recall Nicorette
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Nicorette with NDC 0135-0508 was initiated on 02-20-2014 as a Class III recall due to failed lozenge specifications; lozenges are overly thick, overly soft, and sub and superpotent. The latest recall number for this product is D-1245-2014 and the recall is currently terminated as of 01-20-2017 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1245-2014 | 02-20-2014 | 04-30-2014 | Class III | 834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials | 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. | Terminated |
| D-1246-2014 | 02-20-2014 | 04-30-2014 | Class III | 189,900 20 ct Vials, 145,068 81 ct Vials | Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.