Medications & Supplements/Over-the-Counter

GLAXOSMITHKLINE NEBRASKA: Prevacid 24HR (Lansoprazole) Recalled for Manufacturing Deviations

Agency Publication Date: October 5, 2018

Summary

Approximately 5.5 million bottles of Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, have been recalled. This over-the-counter heartburn medication was manufactured by GlaxoSmithKline Nebraska and distributed in 14-count bottles packaged in one, two, or three-bottle cartons. The recall was initiated due to deviations from current Good Manufacturing Practice (CGMP) standards, which are the regulations required by the FDA to ensure pharmaceutical quality and safety. Consumers who have these products should check their lot numbers and expiration dates immediately and consult with a healthcare provider regarding continued use.

Risk

Manufacturing deviations mean the product may not have been produced under the strict quality control standards required to ensure its safety, purity, and effectiveness. While no specific injuries or adverse reactions were reported in the data, failing to follow these manufacturing protocols can lead to inconsistent drug quality or potential contamination.

What You Should Do

Check your medicine cabinet for Prevacid 24HR (Lansoprazole) 15 mg delayed-release capsules in 1-bottle (NDC: 0067-6286-14), 2-bottle (NDC: 0067-6286-28), or 3-bottle (NDC: 0067-6286-42) cartons.
Verify your lot numbers and expiration dates on the side of the carton or bottle. For 1-bottle cartons, affected lots include 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 (Exp 7/31/2018), M721601MA (Exp 7/31/2018), 379H (Exp 8/31/2018), A93E (Exp 10/31/2018), AE2S (Exp 10/31/2018), GB7D (Exp 11/30/2019), GS5B (Exp 11/30/2019), M801001MA (Exp 11/30/2019), M807901MA (Exp 11/30/2019), M807902MA (Exp 11/30/2019), and D88E (Exp 11/30/2020).
For 2-bottle cartons, verify lot numbers GJ0440 (Exp 1/31/2019), LE6J (Exp 7/31/2018), and A93E (Exp 10/31/2018).
For 3-bottle cartons, verify over 50 specific lots including 17D19N (Exp 8/31/2018), 1GE2743 (Exp 9/30/2018), GA8391 (Exp 10/31/2018), GA6310 (Exp 11/30/2018), GH8818 (Exp 1/31/2018), AF5C (Exp 4/30/2019), FL8P (Exp 5/31/2019), P77N (Exp 8/31/2019), 728J (Exp 10/31/2019), H43X (Exp 11/30/2019), T73J (Exp 2/29/2019), and MC2P (Exp 1/31/2021).
If your lot number is listed, contact your healthcare provider or pharmacist for guidance regarding your treatment and to determine if you should stop using the medication.
Return any unused product to the pharmacy or place of purchase for a refund.
Contact GlaxoSmithKline or the distributor for further instructions on the recall process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg (1-bottle carton)

Model:

NDC: 0067-6286-14

Lot Numbers:

GE2743 (Exp 9/30/2018)

GE4570 (Exp 9/30/2018)

GG0536 (Exp 9/30/2018)

GE3445 (Exp 11/30/2018)

GG4810 (Exp 11/30/2018)

A38M (Exp 12/31/2018)

K63J (Exp 4/30/2018)

H24T (Exp 5/31/2018)

RS4U (Exp 7/31/2018)

M721601MA (Exp 7/31/2018)

379H (Exp 8/31/2018)

A93E (Exp 10/31/2018)

AE2S (Exp 10/31/2018)

GB7D (Exp 11/30/2019)

GS5B (Exp 11/30/2019)

M801001MA (Exp 11/30/2019)

M807901MA (Exp 11/30/2019)

M807902MA (Exp 11/30/2019)

D88E (Exp 11/30/2020)

Date Ranges: April 2018 - November 2020

Product: Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg (2-bottle carton)

Model:

NDC: 0067-6286-28

Lot Numbers:

GJ0440 (Exp 1/31/2019)

LE6J (Exp 7/31/2018)

A93E (Exp 10/31/2018)

Date Ranges: July 2018 - January 2019

Product: Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg (3-bottle carton)

Model:

NDC: 0067-6286-42

Lot Numbers (72):

17D19N (Exp 8/31/2018)

1GE2743 (Exp 9/30/2018)

GE4570 (Exp 9/30/2018)

GG0536 (Exp 9/30/2018)

GA8391 (Exp 10/31/2018)

GE3445 (Exp 11/30/2018)

GA6310 (Exp 11/30/2018)

GG1094 (Exp 1/31/2018)

GH1913 (Exp 1/31/2018)

GH8818 (Exp 1/31/2018)

M703002EH (Exp 1/31/2018)

M703003EH (Exp 1/31/2018)

M703004EH (Exp 1/31/2018)

M703006EH (Exp 1/31/2018)

M703007EH (Exp 1/31/2018)

M703008EH (Exp 1/31/2018)

M713101EH (Exp 1/31/2018)

M707401MB (Exp 1/31/2018)

M707402MB (Exp 1/31/2018)

M707403MB (Exp 1/31/2018)

M707404MB (Exp 1/31/2018)

M707405MB (Exp 1/31/2018)

M707406MB (Exp 1/31/2018)

M721201MB (Exp 1/31/2018)

M717001MA (Exp 1/31/2018)

M717002MA (Exp 1/31/2018)

AF5C (Exp 4/30/2019)

AK2T (Exp 4/30/2019)

AV5T (Exp 4/30/2019)

M713102EH (Exp 4/30/2019)

M713104EH (Exp 4/30/2019)

M716001EH (Exp 4/30/2019)

M716002EH (Exp 4/30/2019)

M716003EH (Exp 4/30/2019)

M716004EH (Exp 4/30/2019)

M716005EH (Exp 4/30/2019)

M721202MB (Exp 4/30/2019)

M721203MB (Exp 4/30/2019)

M721204MB (Exp 4/30/2019)

M717003MA (Exp 4/30/2019)

M717004MA (Exp 4/30/2019)

M717005MA (Exp 4/30/2019)

M717006MA (Exp 4/30/2019)

FL8P (Exp 5/31/2019)

FM4K (Exp 5/31/2019)

M720505EH (Exp 5/31/2019)

M720507EH (Exp 5/31/2019)

M720508EH (Exp 5/31/2019)

M720509EH (Exp 5/31/2019)

M721205MB (Exp 5/31/2019)

Date Ranges: January 2018 - January 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81041

Status: Resolved

Manufacturer: GLAXOSMITHKLINE NEBRASKA

Sold By: GSK Consumer Healthcare; Pharmacies

Manufactured In: United States

Units Affected: 5,548,673 bottles

Distributed To: Nationwide

Agency Last Updated: October 23, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medicine cabinet for Prevacid 24HR (Lansoprazole) 15 mg delayed-release capsules in 1-bottle (NDC: 0067-6286-14), 2-bottle (NDC: 0067-6286-28), or 3-bottle (NDC: 0067-6286-42) cartons.

Verify your lot numbers and expiration dates on the side of the carton or bottle. For 1-bottle cartons, affected lots include 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 (Exp 7/31/2018), M721601MA (Exp 7/31/2018), 379H (Exp 8/31/2018), A93E (Exp 10/31/2018), AE2S (Exp 10/31/2018), GB7D (Exp 11/30/2019), GS5B (Exp 11/30/2019), M801001MA (Exp 11/30/2019), M807901MA (Exp 11/30/2019), M807902MA (Exp 11/30/2019), and D88E (Exp 11/30/2020).

For 2-bottle cartons, verify lot numbers GJ0440 (Exp 1/31/2019), LE6J (Exp 7/31/2018), and A93E (Exp 10/31/2018).

For 3-bottle cartons, verify over 50 specific lots including 17D19N (Exp 8/31/2018), 1GE2743 (Exp 9/30/2018), GA8391 (Exp 10/31/2018), GA6310 (Exp 11/30/2018), GH8818 (Exp 1/31/2018), AF5C (Exp 4/30/2019), FL8P (Exp 5/31/2019), P77N (Exp 8/31/2019), 728J (Exp 10/31/2019), H43X (Exp 11/30/2019), T73J (Exp 2/29/2019), and MC2P (Exp 1/31/2021).

If your lot number is listed, contact your healthcare provider or pharmacist for guidance regarding your treatment and to determine if you should stop using the medication.

Return any unused product to the pharmacy or place of purchase for a refund.

Contact GlaxoSmithKline or the distributor for further instructions on the recall process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg (1-bottle carton)

Model:

NDC: 0067-6286-14

Lot Numbers:

GE2743 (Exp 9/30/2018)

GE4570 (Exp 9/30/2018)

GG0536 (Exp 9/30/2018)

GE3445 (Exp 11/30/2018)

GG4810 (Exp 11/30/2018)

A38M (Exp 12/31/2018)

K63J (Exp 4/30/2018)

H24T (Exp 5/31/2018)

RS4U (Exp 7/31/2018)

M721601MA (Exp 7/31/2018)

379H (Exp 8/31/2018)

A93E (Exp 10/31/2018)

AE2S (Exp 10/31/2018)

GB7D (Exp 11/30/2019)

GS5B (Exp 11/30/2019)

M801001MA (Exp 11/30/2019)

M807901MA (Exp 11/30/2019)

M807902MA (Exp 11/30/2019)

D88E (Exp 11/30/2020)

Date Ranges: April 2018 - November 2020

Product: Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg (2-bottle carton)

Model:

NDC: 0067-6286-28

Lot Numbers:

GJ0440 (Exp 1/31/2019)

LE6J (Exp 7/31/2018)

A93E (Exp 10/31/2018)

Date Ranges: July 2018 - January 2019

Product: Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg (3-bottle carton)

Model:

NDC: 0067-6286-42

Lot Numbers (72):

17D19N (Exp 8/31/2018)

1GE2743 (Exp 9/30/2018)

GE4570 (Exp 9/30/2018)

GG0536 (Exp 9/30/2018)

GA8391 (Exp 10/31/2018)

GE3445 (Exp 11/30/2018)

GA6310 (Exp 11/30/2018)

GG1094 (Exp 1/31/2018)

GH1913 (Exp 1/31/2018)

GH8818 (Exp 1/31/2018)

M703002EH (Exp 1/31/2018)

M703003EH (Exp 1/31/2018)

M703004EH (Exp 1/31/2018)

M703006EH (Exp 1/31/2018)

M703007EH (Exp 1/31/2018)

M703008EH (Exp 1/31/2018)

M713101EH (Exp 1/31/2018)

M707401MB (Exp 1/31/2018)

M707402MB (Exp 1/31/2018)

M707403MB (Exp 1/31/2018)

M707404MB (Exp 1/31/2018)

M707405MB (Exp 1/31/2018)

M707406MB (Exp 1/31/2018)

M721201MB (Exp 1/31/2018)

M717001MA (Exp 1/31/2018)

M717002MA (Exp 1/31/2018)

AF5C (Exp 4/30/2019)

AK2T (Exp 4/30/2019)

AV5T (Exp 4/30/2019)

M713102EH (Exp 4/30/2019)

M713104EH (Exp 4/30/2019)

M716001EH (Exp 4/30/2019)

M716002EH (Exp 4/30/2019)

M716003EH (Exp 4/30/2019)

M716004EH (Exp 4/30/2019)

M716005EH (Exp 4/30/2019)

M721202MB (Exp 4/30/2019)

M721203MB (Exp 4/30/2019)

M721204MB (Exp 4/30/2019)

M717003MA (Exp 4/30/2019)

M717004MA (Exp 4/30/2019)

M717005MA (Exp 4/30/2019)

M717006MA (Exp 4/30/2019)

FL8P (Exp 5/31/2019)

FM4K (Exp 5/31/2019)

M720505EH (Exp 5/31/2019)

M720507EH (Exp 5/31/2019)

M720508EH (Exp 5/31/2019)

M720509EH (Exp 5/31/2019)

M721205MB (Exp 5/31/2019)

Date Ranges: January 2018 - January 2021