The Recall Desk
LowFDA (Drugs)·D-1244-2014·Announced 2014-04-30

GlaxoSmithKline Recalls Nicorette and Nicoderm CQ Products for Quality Failures

GlaxoSmithKline is recalling specific lots of Nicorette and Nicoderm CQ products because the lozenges failed quality specifications, including being overly thick, soft, and having incorrect potency.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issues are quality-related (thickness, softness, potency) rather than acute safety hazards like contamination or choking.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling 12,162 pallets of Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination products. The recall covers specific lots distributed nationwide in the United States. The affected products are over-the-counter (OTC) only.

The recall was initiated because the lozenges failed to meet specifications. Specifically, the lozenges were found to be overly thick, overly soft, and sub and superpotent. The affected lot numbers are 12K16W, 12K27N, 12K27W, 12K29N, 13K20W, 13K20W1, and 13K25N.

Consumers should stop using the affected products and return them to the place of purchase for a refund or contact GlaxoSmithKline for further instructions.

The recalled product

Product
Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
Manufacturer
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Category
Drug — Nicotine Replacement Therapy
Hazard
Affected units
12,162

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)

  • Lot #12K16W (exp 5/14)
  • 12K27N (exp 6/14)
  • 12K27W (exp 6/14)
  • 12K29N (exp 6/14)
  • 13K20W (exp 6/15)
  • 13K20W1 (exp 6/15) & 13K25N (exp 6/15).

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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