The Recall Desk
ModerateFDA (Drugs)·D-1243-2014·Announced 2014-04-30

GlaxoSmithKline Recalls Nicorette Lozenges Due to Quality Failures

GlaxoSmithKline is recalling Nicorette 4 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 recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, fitting the Moderate severity criteria for minor quality deviations without reported injuries.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling specific lots of Nicorette 4 mg Mint Flavor lozenges. The recall covers 81-count and 189-count vials distributed nationwide in the United States. The affected products are identified by specific lot numbers and expiration dates listed in the recall notice.

The recall was initiated because the lozenges failed to meet required specifications. Specifically, the lozenges were found to be overly thick, overly soft, and sub or superpotent. This means the amount of nicotine in the lozenges may be lower or higher than intended.

Consumers who have these specific products should stop using them and return them to the place of purchase for a refund or contact GlaxoSmithKline for instructions.

The recalled product

Product
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
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 # 13728 (exp 8/14)
  • 13771 (exp 10/14)
  • 13993 (exp 1/15) & 13994 (exp 1/15)
  • 189 Ct Vial Lot # 12H23N (exp 5/14)
  • 12K02N (exp 6/14)
  • 12K06N (exp 10/14)
  • 12K30N (exp 10/14)
  • 12L04N (exp 10/14)
  • 12L04N1 (exp 10/14)
  • 13A08N (exp 10/14)
  • 13B08N (exp 1/15)
  • 13D02N (2/15)
  • 13E01N (exp 3/15)
  • 13E21N (exp 4/15)
  • 13G18N (exp 5/15)
  • 13H06N (exp 5/15)
  • 13H07N (exp 7/15)
  • 13H30N (exp 7/15)
  • 13H30NN (exp 7/15)
  • 13I25N (exp 7/15)

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 →

Related recalls

Same manufacturer · GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

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Same hazard · quality failure

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