The Recall Desk
ModerateFDA (Drugs)·D-1242-2014·Announced 2014-04-30

Nicorette Lozenges Recalled for Thickness and Potency Failures

GlaxoSmithKline is recalling Nicorette 2 mg lozenges because they failed specifications for thickness, softness, and potency.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The defects are quality control issues (thickness, softness, potency) without reported injuries.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling Nicorette 2 mg Mint Flavor lozenges in 81-count and 189-count cartons. The recall covers specific lots of the product distributed nationwide in the United States.

The recall was initiated because the lozenges failed to meet specifications. The affected products were found to be overly thick, overly soft, and sub or superpotent. The source text does not report any illnesses or injuries associated with these defects.

Consumers with the affected products should stop using them and return them to the point of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product
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.
Manufacturer
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Category
Drug — Over-the-Counter Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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