The Recall Desk
ModerateFDA (Drugs)·D-1241-2014·Announced 2014-04-30

GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

GlaxoSmithKline is recalling specific lots of Nicorette 2 mg 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 the product is not likely to cause adverse health consequences. The hazard involves quality control failures (potency and physical characteristics) rather than acute toxicity or contamination.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling specific lots of Nicorette (nicotine polacrilex) 2 mg lozenges. The affected products include 72-count and 108-count cartons distributed under the Nicorette brand, as well as private-label versions sold as Nicotine Lozenge Kroger and Nicotine Walgreens. The recall covers approximately 488,628 72-count vials and 255,594 108-count 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 who have purchased these specific lots should stop using the product and return it to the place of purchase for a refund. The recall number is D-1241-2014. Specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
NICORETTE (NICOTINE POLACRILEX)
Brand
NICORETTE
Manufacturer
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Category
Drug — OTC Nicotine Replacement
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)

  • Labeled A) 72 Count Vial
  • Lot # 13404 (exp 4/14)
  • 13499 (exp 5/14)
  • 13549 (exp 6/14)
  • 14004 (exp 1/15)
  • 14079 (exp 2/15)
  • 14178 (exp 5/15)
  • 14297 (exp 7/15) & 14425 (exp 9/15)
  • 108 Ct Vial: Lot # 13449 (exp 5/14)
  • 13657 (exp 8/14)
  • 13723 (exp 8/14)
  • 13781 (exp 11/14)
  • 13867 (exp 11/14)
  • 13897 (exp 12/14)
  • 13960 (exp 1/15)
  • 13981 (exp 12/14)
  • 14016 (exp 2/15)
  • 14254 (exp 7/15)
  • 14305 (exp 7/15)
  • 14341 (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 brand · NICORETTE

Same manufacturer · GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

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Same hazard · subpotency

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