The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1246-2014·Announced 2014-04-30

GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

GlaxoSmithKline is recalling specific lots of Nicorette lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 issue involves quality control failures (potency and physical characteristics) rather than a high-risk pathogen or structural defect.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling specific lots of Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor. The affected products include 20-count and 81-count vials distributed nationwide in the United States. The recall involves approximately 189,900 20-count vials and 145,068 81-count vials.

The recall was initiated because the lozenges failed to meet quality 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 contact GlaxoSmithKline for a refund or replacement. The affected lot numbers and expiration dates are: 20-count vials Lot #14337 (exp 7/15), 14398 (exp 9/15), and 14510 (exp 9/15); 81-count vials Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (exp 9/15), and 14563 (exp 9/15).

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 (6)

  • (20 ct) Lot #14337 (exp 7/15)
  • 14398 (exp 9/15) & 14510 (exp 9/15)
  • (81 ct) Lot #14336 (exp 7/15)
  • 14347 (exp 7/15)
  • 14378 (9/15)
  • 14563 (exp 9/15)

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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