GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications
GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed specifications for thickness, softness, and potency.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The defects are quality control issues (thickness, softness, potency) without reported injuries.
Plain-English summary
GlaxoSmithKline Consumer Healthcare is recalling specific lots of Nicotine polacrilex lozenges, 2 mg, Cherry Flavor. The affected products include Nicorette, Nicotine Lozenge Kroger, and Nicotine Walgreens in 72, 81, and 108 count vials. The recall covers approximately 187,398 vials distributed nationwide.
The recall was initiated because the lozenges failed specifications. Specifically, the lozenges were found to be overly thick, overly soft, and sub and superpotent. The source text does not report any illnesses or injuries associated with the use of these products.
Consumers should check their vials for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using the lozenges and contact the distributor or manufacturer for a refund or replacement.
The recalled product
- Product
- Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 01
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 (9)
- Labeled A) 72 Ct Vial: Lot #13468 (exp 4/14)
- 13618 (exp 6/14) & 14105 (exp 2/15)
- 81 Ct- Vial
- Lot #13815 (exp 10/14)
- 13864 (exp 11/14) & 13941 (exp 12/14)
- 108 Ct- Vial
- Lot # 13574 (exp 7/14). Labeled B) 72 Ct Vial
- 13642 (exp 7/14)
- 13770 (exp 8/14) & 13875 (exp 11/14).
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
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