The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1240-2014·Announced 2014-04-30

GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

GlaxoSmithKline is recalling specific lots of Nicorette 4 mg 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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard 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) 4 mg lozenges. The recall includes 72-count, 81-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 affected products were distributed nationwide in the United States.

The recall was initiated because the lozenges failed to meet quality specifications. According to the source text, the affected lozenges are overly thick, overly soft, and sub or superpotent. The recall covers approximately 603,696 72-count vials and 191,040 108-count vials.

Consumers should check their lozenge cartons for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact GlaxoSmithKline or the retailer for a refund or replacement.

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 Ct Vial: Lot # 13434 (exp 4/14)
  • 13546 (exp 5/14)
  • 13907 (exp 11/14)
  • 14020 (exp 1/15)
  • 14107 (exp 3/15)
  • 14183 (exp 4/15)
  • 14273 (exp 7/15)
  • 14335 (exp 8/15)
  • & 14421 (exp 9/15)
  • 12F27N (exp 4/14)
  • 12K01N (exp 5/14)
  • 13A25N (exp 11/14) & 13C18N (exp 1/15)
  • 108 Ct Vial
  • Lot # 13383 (exp 4/14)
  • 13626 (exp 5/14)
  • 13725 (exp 10/14)
  • 13861 (exp 12/14)
  • 13980 (exp 1/15)
  • 13982 (exp 1/15)
  • 14091 (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 →

Related recalls

Same brand · NICORETTE

Same manufacturer · GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

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Same hazard · quality control

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