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Glaxosmithkline Consumer Healthcare Holdings

Glaxosmithkline Consumer Healthcare Holdings Recalls

All product recalls associated with Glaxosmithkline Consumer Healthcare Holdings.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

May 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 68 recalls

Advil Sinus Congestion (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Advil Liqui-Gel Mini (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Ibuprofen Oral Suspension (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

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Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Advil Liqui-Gel Minis (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Prevacid 24HR (GlaxoSmithKline) – CGMP Deviation (2018)

CGMP deviations

Class IIModerate

FDASep 26, 2018Nationwide• GLAXOSMITHKLINE NEBRASKA

Ventolin HFA Inhaler (GlaxoSmithKline) – Delivery System Defect (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate

Class IIModerate

FDAMay 16, 2017Nationwide• GlaxoSmithKline, LLC

Ventolin HFA (GlaxoSmithKline) – Defective Delivery System (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

Class IIModerate

FDAMar 22, 2017Nationwide• GlaxoSmithKline, LLC

Bactroban Nasal (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Bactroban Ointment (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• GlaxoSmithKline, LLC

Ventolin HFA Inhaler (GlaxoSmithKline) – Insufficient Propellant (2015)

Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

Class IIModerate

FDADec 3, 2015MS, VT• GlaxoSmithKline, LLC

Bactroban Cream (GSK) – Contamination Risk (2015)

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Class IIModerate

FDAAug 13, 2015Nationwide• GlaxoSmithKline, LLC.

Mupirocin Calcium Cream (GSK) – Contamination Risk (2015)

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Class IIModerate

FDAAug 13, 2015Nationwide• GlaxoSmithKline, LLC.

Bactroban Ointment (GSK) – Contamination Risk (2015)

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Class IIModerate

FDAAug 13, 2015Nationwide• GlaxoSmithKline, LLC.

Bactroban Nasal Ointment (GlaxoSmithKline) – Contamination Risk (2015)

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Class IIModerate

FDAAug 13, 2015Nationwide• GlaxoSmithKline, LLC.

Sensodyne Complete Protection (GlaxoSmithKline) – wood fragments (2015)

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Class IIModerate

FDAJul 15, 2015Nationwide• GlaxoSmithkline Consmer Healthcare

Biotene PBF Toothpaste (GlaxoSmithKline) – wood fragments (2015)

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Class IIModerate

FDAJul 15, 2015Nationwide• GlaxoSmithkline Consmer Healthcare

Biotene Gentle Mint Gel (GlaxoSmithKline) – wood fragments (2015)

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Class IIModerate

FDAJul 15, 2015Nationwide• GlaxoSmithkline Consmer Healthcare

Sensodyne Repair & Protect (GlaxoSmithKline) – wood fragments (2015)

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Class IIModerate

FDAJul 15, 2015Nationwide• GlaxoSmithkline Consmer Healthcare