CLASS III Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report
Nicotine polacrilex lozenge, 4 mg, Original Flavor cartons recalled
GlaxoSmithKline Consumer Healthcare; is recalling Nicotine polacrilex lozenge, 4 mg, Original 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-1240-2014
- FDA event ID
- 67800
- Recalling firm
- GlaxoSmithKline Consumer Healthcare;, Aiken, SC
- Brand
- Nicorette
- Manufacturer
- Haleon US Holdings LLC
- 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, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Nicotine polacrilex lozenge, 4 mg, Original Flavor cartons recalled?
Yes. GlaxoSmithKline Consumer Healthcare; recalled Nicotine polacrilex lozenge, 4 mg, Original Flavor cartons on 20 Feb 2014. The recall is Class III and its status is Terminated. Recall number D-1240-2014.
Why was it recalled?
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Which lots are affected?
Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14).
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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, 2 mg, Mint 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, 2 mg recalled by GlaxoSmithKline Consumer | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
Other Nicotine Polacrilex recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nicotine Polacrilex Lozenge, 2 mg Mint Mini recalled by Perrigo HollandCareone Nicotine | Perrigo Holland | Potency & Assay | 7 states |
| Drug | CLASS III | Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg recalledNicorette | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg recalledNicorette | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |
| Drug | CLASS III | Nicotine polacrilex lozenge, 2 mg, Original Flavor cartons recalledNicorette | GlaxoSmithKline Consumer Healthcare; | Potency & Assay | Nationwide |