CLASS III Drug recall · Reported 3 Sep 2014 · FDA Enforcement Report

Nicotine Polacrilex Lozenge, 2 mg Mint Mini recalled by Perrigo Holland

Perrigo Holl is recalling Nicotine Polacrilex Lozenge, 2 mg Mint Mini, distributed in 7 states. The recall was initiated on 19 Aug 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCartons of 27 ct Tubes: Lot #: 2MV1074, Expiry: 09/14; Lot #: 2MV1124, Expiry: 09/14; Lot #: 2MV1142, Expiry: 09/14; Lot #: 2MV1143, Expiry: 09/14; Lot #: 3AV0528, Expiry: 09/14; Lot #: 3FV0575, Expiry: 09/14; Lot #: 3FV0535, Expiry: 03/15; Lot #: 3FV0537, Expiry: 03/15; Lot #: 3FV0576, Expiry: 03/15; Lot #: 3FV0579, Expiry: 03/15; Lot #: 3FV0615, Expiry: 03/15; Lot #: 3FV0739, Expiry: 03/15; Lot #: 3FV0742, Expiry: 03/15, Lot #: 3GV0713, Expiry: 03/15; Lot #: 3GV0715, Expiry: 03/15, Lot #: 3FV0421, Expiry: 03/15, Lot #: 3FV0422, Expiry: 03/15; Lot #: 3FV0423, Expiry: 03/15; Lot #: 3FV0740, Expiry: 03/15. 20 Ct Stretchcard: Lot #: 3FV0520, Expiry: 03/15.

NDC41520-734, 59779-734, 49035-734

UPC0012345678905

Quantity recalled366,936 Tubes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1558-2014
FDA event ID: 69048
Recalling firm: Perrigo Holl, Holland, MI
Brand: Careone Nicotine
Manufacturer: American Sales Company
Classification: Class III
Status: Terminated
Recall initiated: 19 Aug 2014
FDA classified: 22 Aug 2014
Reported: 3 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Potency & Assay
Drug class: Cold & Cough Medicine

Timeline

19 Aug 2014	Recall initiated by company
22 Aug 2014	Classified by FDA	+3 days
3 Sep 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.

Where it was distributed

U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.

Arkansas Illinois Minnesota Ohio Oregon Pennsylvania Rhode Island

Stores named: Walmart, Kroger, Target, Walgreens, CVS, Rite Aid

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

Which lots are affected?

Cartons of 27 ct Tubes: Lot #: 2MV1074, Expiry: 09/14; Lot #: 2MV1124, Expiry: 09/14; Lot #: 2MV1142, Expiry: 09/14; Lot #: 2MV1143, Expiry: 09/14; Lot #: 3AV0528, Expiry: 09/14; Lot #: 3FV0575, Expiry: 09/14; Lot #: 3FV0535, Expiry: 03/15; Lot #: 3FV0537, Expiry: 03/15; Lot #: 3FV0576, Expiry: 03/15; Lot #: 3FV0579, Expiry: 03/15; Lot #: 3FV0615, Expiry: 03/15; Lot #: 3FV0739, Expiry: 03/15; Lot #: 3FV0742, Expiry: 03/15, Lot #: 3GV0713, Expiry: 03/15; Lot #: 3GV0715, Expiry: 03/15, Lot #: 3FV0421, Expiry: 03/15, Lot #: 3FV0422, Expiry: 03/15; Lot #: 3FV0423, Expiry: 03/15; Lot #: 3FV0740, Expiry: 03/15. 20 Ct Stretchcard: Lot #: 3FV0520, Expiry: 03/15.

Where was it sold?

U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other Nicotine Polacrilex recalls

All 13

Reported	Class	Recall	Company	Reason	Where
30 Apr 2014Drug	CLASS III	Nicotine polacrilex lozenge, 4 mg, Cherry Flavor cartons recalled	GlaxoSmithKline Consumer Healthcare;	Potency & Assay	Nationwide
30 Apr 2014Drug	CLASS III	Nicotine polacrilex lozenge, 2 mg, Mint Flavor cartons recalled	GlaxoSmithKline Consumer Healthcare;	Potency & Assay	Nationwide
30 Apr 2014Drug	CLASS III	Nicotine polacrilex lozenge, 4 mg, Mint Flavor recalled	GlaxoSmithKline Consumer Healthcare;	Potency & Assay	Nationwide
30 Apr 2014Drug	CLASS III	Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg recalledNicorette	GlaxoSmithKline Consumer Healthcare;	Potency & Assay	Nationwide
30 Apr 2014Drug	CLASS III	Nicotine polacrilex lozenge, 4 mg, Original Flavor cartons recalledNicorette	GlaxoSmithKline Consumer Healthcare;	Potency & Assay	Nationwide