CLASS II Drug recall · Reported 17 Oct 2018 · FDA Enforcement Report

Prevacid 24HR (Lansoprazole) delayed-release capsules recalled

Glaxosmithkline Nebraska is recalling Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg per bottle in a carton, distributed nationwide in the US. The recall was initiated on 26 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1-bottle cartons lot #: GE2743, GE4570, GG0536, Exp 9/30/2018; GE3445, GG4810, Exp 11/30/2018; A38M, Exp 12/31/2018; K63J, Exp 4/30/2018; H24T, Exp 5/31/2018; RS4U, M721601MA, Exp 7/31/2018; 379H, Exp 8/31/2018; A93E, AE2S, Exp 10/31/2018; GB7D, GS5B, M801001MA, M807901MA, M807902MA, exp 11/30/2019; D88E, Exp 11/30/2020 2-bottle cartons lot#: GJ0440, Exp 1/31/2019; LE6J, Exp 7/31/2018; A93E, Exp 10/31/2018 3-bottle cartons lot#: 17D19N, Exp 8/31/2018; 1GE2743, GE4570, GG0536, Exp 9/30/2018; GA8391, Exp 10/31/2018; GE3445, GA6310, Exp 11/30/2018; GG1094, GH1913, GH8818, M703002EH, M703003EH, M703004EH, M703006EH, M703007EH, M703008EH, M713101EH, M707401MB, M707402MB, M707403MB, M707404MB, M707405MB, M707406MB, M721201MB, M717001MA, M717002MA, Exp 1/31/2018; AF5C, AK2T, AV5T, M713102EH, M713104EH, M716001EH, M716002EH, M716003EH, M716004EH, M716005EH, M721202MB, M721203MB, M721204MB, M717003MA, M717004MA, M717005MA, M717006MA, Exp 4/30/2019; FL8P, FM4K, M720505EH, M720507EH, M720508EH, M720509EH, M721205MB, M721206MB, M721207MB, Exp 5/31/2019; P77N, P77P, PN3Y, R72E, Exp 8/31/2019; 728J, 728K, 728L, 8E6T, A93E, Exp 10/31/2019; H43X, HT4P, M85L, Exp 11/30/2019; T73J, UT9X, UV7Y, Exp 2/29/2019; BR4Y, FN2N, Exp 11/30/2020; MC2P, MJ9F, RC2T, Exp 1/31/2021

Quantity recalled5,548,673 bottles

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-0088-2019
FDA event ID: 81041
Recalling firm: Glaxosmithkline Nebraska, Lincoln, NE
Classification: Class II
Status: Terminated
Recall initiated: 26 Sep 2018
FDA classified: 23 Oct 2018
Reported: 17 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Stomach & Acid Reflux Medication

Timeline

26 Sep 2018	Recall initiated by company
17 Oct 2018	Published in enforcement report	+21 days
23 Oct 2018	Classified by FDA	+6 days

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

Reason for recall

CGMP deviations

Product as listed by the FDA

Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.

Where it was distributed

Nationwide USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

CGMP deviations

Which lots are affected?

1-bottle cartons lot #: GE2743, GE4570, GG0536, Exp 9/30/2018; GE3445, GG4810, Exp 11/30/2018; A38M, Exp 12/31/2018; K63J, Exp 4/30/2018; H24T, Exp 5/31/2018; RS4U, M721601MA, Exp 7/31/2018; 379H, Exp 8/31/2018; A93E, AE2S, Exp 10/31/2018; GB7D, GS5B, M801001MA, M807901MA, M807902MA, exp 11/30/2019; D88E, Exp 11/30/2020 2-bottle cartons lot#: GJ0440, Exp 1/31/2019; LE6J, Exp 7/31/2018; A93E, Exp 10/31/2018 3-bottle cartons lot#: 17D19N, Exp 8/31/2018; 1GE2743, GE4570, GG0536, Exp 9/30/2018; GA8391, Exp 10/31/2018; GE3445, GA6310, Exp 11/30/2018; GG1094, GH1913, GH8818, M703002EH, M703003EH, M703004EH, M703006EH, M703007EH, M703008EH, M713101EH, M707401MB, M707402MB, M707403MB, M707404MB, M707405MB, M707406MB, M721201MB, M717001MA, M717002MA, Exp 1/31/2018; AF5C, AK2T, AV5T, M713102EH, M713104EH, M716001EH, M716002EH, M716003EH, M716004EH, M716005EH, M721202MB, M721203MB, M721204MB, M717003MA, M717004MA, M717005MA, M717006MA, Exp 4/30/2019; FL8P, FM4K, M720505EH, M720507EH, M720508EH, M720509EH, M721205MB, M721206MB, M721207MB, Exp 5/31/2019; P77N, P77P, PN3Y, R72E, Exp 8/31/2019; 728J, 728K, 728L, 8E6T, A93E, Exp 10/31/2019; H43X, HT4P, M85L, Exp 11/30/2019; T73J, UT9X, UV7Y, Exp 2/29/2019; BR4Y, FN2N, Exp 11/30/2020; MC2P, MJ9F, RC2T, Exp 1/31/2021

Where was it sold?

Nationwide USA and Puerto Rico

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.