Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    (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), 13487 (exp 6/14), 13559 (exp 6/14), 13575 (exp 7/14), 13594 (exp 7/14), 13678 (exp 8/14), 13737 (exp 9/14), 13797 (exp 10/14), 13817 (exp 11/14), 13891 (exp 11/14), 13996 (exp 1/15), 14104 (exp 3/15), 14127 (exp 4/15), 14131 (exp 4/15), 14137 (exp 4/15), 14142 (exp 4/15), 14149 (exp 4/15), 14186 (exp 5/15), 14198 (exp 5/15), 14259 (exp 7/15), 14354 (exp 9/15), 14355 (exp 9/15), 14438 (exp 10/15), 14455 (exp 10/15) & 14477 (ex[ 10/15); (135 ct) Lot #12J08N (exp 8/14), 12K06N (exp 8/14), 12K30N (exp 8/14), 12L18N (exp 8/14), 13B04N (exp 11/14), 13C11N (exp 8/15), 13F18N (exp 5/15), 13H05N (exp 5/15), 13I12N (exp 5/15), 13I28N (exp 5/15), 13K12N (exp 9/15), 13K19N (exp 9/15), 13K20N (exp 9/15).
  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:

Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.

Product Codes/Lot Numbers:

(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), 13487 (exp 6/14), 13559 (exp 6/14), 13575 (exp 7/14), 13594 (exp 7/14), 13678 (exp 8/14), 13737 (exp 9/14), 13797 (exp 10/14), 13817 (exp 11/14), 13891 (exp 11/14), 13996 (exp 1/15), 14104 (exp 3/15), 14127 (exp 4/15), 14131 (exp 4/15), 14137 (exp 4/15), 14142 (exp 4/15), 14149 (exp 4/15), 14186 (exp 5/15), 14198 (exp 5/15), 14259 (exp 7/15), 14354 (exp 9/15), 14355 (exp 9/15), 14438 (exp 10/15), 14455 (exp 10/15) & 14477 (ex[ 10/15); (135 ct) Lot #12J08N (exp 8/14), 12K06N (exp 8/14), 12K30N (exp 8/14), 12L18N (exp 8/14), 13B04N (exp 11/14), 13C11N (exp 8/15), 13F18N (exp 5/15), 13H05N (exp 5/15), 13I12N (exp 5/15), 13I28N (exp 5/15), 13K12N (exp 9/15), 13K19N (exp 9/15), 13K20N (exp 9/15).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1245-2014

Related Recalls

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

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