The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1245-2014·Announced 2014-04-30

GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

GlaxoSmithKline is recalling specific lots of Nicorette Lozenges Mini 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 1/5 (Low).

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

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling specific lots of Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor. The affected products include 20, 27, 81, and 135-count vials distributed nationwide in the United States. The recall was initiated because the lozenges failed to meet quality specifications; specifically, they were found to be overly thick, overly soft, and sub or superpotent.

The recall covers approximately 834,072 81-count vials, 414,500 20-count vials, and 9,456 135-count vials. Specific lot numbers and expiration dates are listed in the official recall notice. The product is an over-the-counter medication made in Switzerland and distributed by GlaxoSmithKline Consumer Healthcare, LP, in Moon Township, PA.

Consumers with the affected lots should stop using the product and return it to the place of purchase for a refund or contact GlaxoSmithKline for further instructions. This recall is classified as FDA Class III, indicating that the violation is not likely to cause adverse health consequences.

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)

  • (20 ct) Lot #13444 (exp 05/14)
  • 13486 (exp 06/14)
  • 13547 (exp 06/14)
  • 13619 (exp 06/14)
  • 13675 (exp 07/14)
  • 13833 (exp 11/14)
  • 13921 (exp 11/14)
  • 14008 (exp 1/15)
  • 14150 (exp 4/15)
  • 14195 (exp 4/15)
  • 14260 (exp 7/15)
  • 14286 (exp 7/15)
  • 14379 (exp 9/15)
  • 14428 (exp 9/15)
  • 14463 (exp9/15) & 14507 (exp 10/15)
  • (27 ct) Lot: 14190 (exp 5/15)
  • 14383 (exp 9/15)
  • (81 ct) Lot # 13374 (exp 4/14)
  • 13392 (exp 4/14)
  • 13445 (exp 5/14)

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 brand · NICORETTE

Same manufacturer · GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

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Same hazard · quality failure

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