The Recall Desk
ModerateFDA (Drugs)·D-1239-2014·Announced 2014-04-30

GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

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 indicates a low probability of adverse health consequences. The hazard involves potency deviations and physical defects rather than a high-risk pathogen or structural failure.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling specific lots of Nicotine polacrilex lozenges, 4 mg, Cherry Flavor. The affected products include Nicorette, Nicotine Lozenge Kroger, and Nicotine Walgreens in 72, 81, and 108 count cartons. The recall covers approximately 412,404 vials distributed nationwide in the United States.

The recall was initiated because the lozenges failed to meet required specifications. Specifically, the affected lozenges were found to be overly thick, overly soft, and sub or superpotent. Subpotent lozenges contain less nicotine than labeled, while superpotent lozenges contain more.

Consumers should stop using the affected lozenges and return them to the place of purchase for a refund. Specific lot numbers and expiration dates for the recalled products are listed in the official recall notice.

The recalled product

Product
Nicotine polacrilex lozenge, 4 mg, Cherry 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: 0135-0513-01, 81 Count N
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 (15)

  • Labeled A) 72 Ct Vial
  • Lot # 13481 (exp 5/14)
  • 13674 (exp 5/14)
  • 14056 (exp 2/15)
  • 14092 (exp 3/15)
  • 14258 (exp 7/15)
  • 14450 (exp 10/15)
  • 81 Ct Vial
  • Lot # 13855 (exp 1/15)
  • 13927 (exp 10/14) & 14093 (exp 3/15)
  • 108 Ct Vial
  • Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled B) 72 Ct Vial
  • Lot # 14041 (exp 2/15)
  • 14117 (exp 2/15) & 14268 (exp 4/15)
  • Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14).

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 · potency deviation

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