Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15), 14450 (exp 10/15); 81 Ct Vial, Lot # 13855 (exp 1/15), 13927 (exp 10/14) & 14093 (exp 3/15); 108 Ct Vial, Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled B) 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14).
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
Reason for Recall:
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.

Product Codes/Lot Numbers:

Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15), 14450 (exp 10/15); 81 Ct Vial, Lot # 13855 (exp 1/15), 13927 (exp 10/14) & 14093 (exp 3/15); 108 Ct Vial, Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled B) 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1239-2014

Related Recalls

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Feb 20, 2014 Over-the-Counter Nationwide View Details →