CLASS III Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report
Nicotine polacrilex lozenge, 2 mg, Mint Flavor cartons recalled
GlaxoSmithKline Consumer Healthcare; is recalling Nicotine polacrilex lozenge, 2 mg, Mint Flavor cartons, distributed nationwide in the US. The recall was initiated on 20 Feb 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1242-2014
- FDA event ID
- 67800
- Recalling firm
- GlaxoSmithKline Consumer Healthcare;, Aiken, SC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Feb 2014
- FDA classified
- 18 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cold & Cough Medicine
Timeline
| 20 Feb 2014 | Recall initiated by company | |
| 18 Apr 2014 | Classified by FDA | +57 days |
| 30 Apr 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Which lots are affected?
81 Ct Vial, Lot # 13727 (exp 8/14), 13816 (exp 10/14), & 13965 (exp 12/14); 189 Ct Vial, Lot # 12H17N (exp 4/14), 12H20N (exp 6/14), 12J16N (exp 6/14), 12K03N (exp 9/14), 12L05N (exp 10/14), 12L07N (exp 9/14), 12L17N (exp 10/14), 13A04N (exp 11/14), 13A23N (exp 11/14), 13C04N (exp 1/15), 13C08N (exp 1/15), 13D17N (exp 11/14), 13D18N (exp 1/15), 13D18N1 (exp 3/15), 13E24N (exp 4/15), 13E28N (exp 4/15), 13G16N (exp 4/15), 13G17N (exp 5/14), 13H02N (exp 5/15), 13H22N (exp 5/15), 13I18N (exp 8/15), 13I20N (exp 5/15), 13J24N (exp 8/15), 13J24N1 (exp 9/15), 13K08N (exp 8/15), 13K11N (exp 9/15), 13L11N (exp 10/15) & 13L11N1 (exp 10/15).
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 67800This product is part of a recall event; the main page for the event is Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system recalled.
More recalls from GlaxoSmithKline Consumer Healthcare;
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nicotine polacrilex lozenge, 4 mg, Cherry Flavor cartons recalled | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicotine polacrilex lozenge, 4 mg, Mint Flavor recalled | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg recalledNicorette | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicotine polacrilex lozenge, 4 mg, Original Flavor cartons recalledNicorette | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicotine polacrilex lozenge, 2 mg, Cherry Flavor vials, and vials recalled | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
Other Nicotine Polacrilex recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nicotine Polacrilex Lozenge, 2 mg Mint Mini recalled by Perrigo HollandCareone Nicotine | Perrigo Holl | Potency & Assay | 7 states |
| Drug | CLASS III | Nicotine polacrilex lozenge, 4 mg, Cherry Flavor cartons recalled | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicotine polacrilex lozenge, 4 mg, Mint Flavor recalled | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg recalledNicorette | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicotine polacrilex lozenge, 4 mg, Original Flavor cartons recalledNicorette | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |