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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67800

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 20, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 10

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: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.

D-1238-2014
Recall number
D-1238-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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, Lot #13573 (exp 6/14) & 14257 (exp 7/15). Labeled C) 72 Ct Vial: Lot # 13875 (exp 5/14), 13642 (exp 7/14), 13770 (exp 8/14) & 13875 (exp 11/14).

Distribution pattern

U.S. Nationwide

drug · product 2 of 10

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.

D-1239-2014
Recall number
D-1239-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 Ct Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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).

Distribution pattern

U.S. Nationwide

drug · product 3 of 10

Nicotine polacrilex lozenge, 4 mg, Original 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: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.

D-1240-2014
Recall number
D-1240-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
603,696 72 Ct Vials, 191,040 108 Ct Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14).

Distribution pattern

U.S. Nationwide

drug · product 4 of 10

Nicotine polacrilex lozenge, 2 mg, Original 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: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.

D-1241-2014
Recall number
D-1241-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
488,628 72 Ct Vial, 255,594 108 Ct Vial

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Labeled A) 72 Count Vial, Lot # 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15), 14178 (exp 5/15), 14297 (exp 7/15) & 14425 (exp 9/15); 108 Ct Vial: Lot # 13449 (exp 5/14), 13657 (exp 8/14), 13723 (exp 8/14), 13781 (exp 11/14), 13867 (exp 11/14), 13897 (exp 12/14), 13960 (exp 1/15), 13981 (exp 12/14), 14016 (exp 2/15), 14254 (exp 7/15), 14305 (exp 7/15), 14341 (exp 7/15), 14370 (exp 8/15) & 14465 (exp 11/15). Labeled B) 72 Count Vial, Lot #13417 (exp 5/14), 13570 (exp 6/14), 13974 (exp 1/15), 14089 (exp 2/15), 14225 (exp 5/15), 14269 (exp 7/15), 14311 (exp 7/15) & 14396 (exp 8/15).Labeled C) 108 Ct Vial: Lot #:13656 (exp 8/14), 13753 (exp 9/14).

Distribution pattern

U.S. Nationwide

drug · product 5 of 10

Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.

D-1242-2014
Recall number
D-1242-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
147,684 81 Ct Vials, 130564 189 Ct Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

81 Ct Vial, Lot # 13727 (exp 8/14), 13816 (exp 10/14), & 13965 (exp 12/14); 189 Ct Vial, Lot # 12H17N (exp 4/14), 12H20N (exp 6/14), 12J16N (exp 6/14), 12K03N (exp 9/14), 12L05N (exp 10/14), 12L07N (exp 9/14), 12L17N (exp 10/14), 13A04N (exp 11/14), 13A23N (exp 11/14), 13C04N (exp 1/15), 13C08N (exp 1/15), 13D17N (exp 11/14), 13D18N (exp 1/15), 13D18N1 (exp 3/15), 13E24N (exp 4/15), 13E28N (exp 4/15), 13G16N (exp 4/15), 13G17N (exp 5/14), 13H02N (exp 5/15), 13H22N (exp 5/15), 13I18N (exp 8/15), 13I20N (exp 5/15), 13J24N (exp 8/15), 13J24N1 (exp 9/15), 13K08N (exp 8/15), 13K11N (exp 9/15), 13L11N (exp 10/15) & 13L11N1 (exp 10/15).

Distribution pattern

U.S. Nationwide

drug · product 6 of 10

Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.

D-1243-2014
Recall number
D-1243-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
146,424 81 Ct. Vials, 105,091 189 Ct Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15).

Distribution pattern

U.S. Nationwide

drug · product 7 of 10

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.

D-1244-2014
Recall number
D-1244-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
12,162 Pallets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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 pattern

U.S. Nationwide

drug · product 8 of 10

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.

D-1245-2014
Recall number
D-1245-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

(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).

Distribution pattern

U.S. Nationwide

drug · product 9 of 10

Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.

D-1246-2014
Recall number
D-1246-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
189,900 20 ct Vials, 145,068 81 ct Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

(20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15)

Distribution pattern

U.S. Nationwide

drug · product 10 of 10

Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.

D-1247-2014
Recall number
D-1247-2014
Initiated
February 20, 2014
Classification
Class III
Status
Terminated
Quantity
150 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #13L05N, Expiry: 8/15

Distribution pattern

U.S. Nationwide