FDA Drug recall D-1246-2014

Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline…

FDA Drug
Class III
terminated
Published 2014-04-30

On 2014-04-30 the FDA classified a Class III recall of Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline… by Glaxosmithkline Consumer Healthcare Dba Glaxosmithkline, citing failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1246-2014
Classification	Class III
Status	terminated
Initiated	2014-02-20
Published	2014-04-30
Last updated	2026-09-13 11:51 UTC
Company	Glaxosmithkline Consumer Healthcare Dba Glaxosmithkline
Distribution	US

Product

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.

Reason

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

Identifiers

ndc	0135-0508-02
ndc	0135-0508-03
ndc	0135-0508-04
ndc	0135-0509-02
ndc	0135-0509-03
ndc	0135-0509-04
code_info	(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)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1246-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.