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GlaxoSmithKline LLC

GlaxoSmithKline LLC Recalls

All product recalls associated with GlaxoSmithKline LLC.

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Recall Summary

Total Recalls

68

Past Year

0

Class I (Serious)

3

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 1–20 of 68 recalls

Tivicay PD (GlaxoSmithKline) – Incorrect Expiration Label (2024)

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

FDAMay 17, 2024Nationwide• GlaxoSmithKline LLC

Anoro Ellipta Inhaler (GSK) – Release Testing Failure (2023)

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

FDADec 12, 2023Nationwide• GlaxoSmithKline LLC

Advil Liqui-Gels Minis (Haleon) – Illegible Label (2022)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

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Class I

High

FDADec 6, 2022Nationwide• Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Advil Liqui-Gels (Haleon) – Illegible Label (2022)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

FDADec 6, 2022Nationwide• Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Advil Tablets 200mg (Haleon) – Illegible Label (2022)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

FDADec 6, 2022Nationwide• Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

TUMS Antacid Berries (GSK) – Glass Mineral Contamination (2022)

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Class IIModerate

FDADec 2, 2022Nationwide• GlaxoSmithKline Consumer Healthcare Holdings LLC

TUMS Antacid Peppermint (GSK) – Glass Mineral Contamination (2022)

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Class IIModerate

FDADec 2, 2022Nationwide• GlaxoSmithKline Consumer Healthcare Holdings LLC

Tivicay (GlaxoSmithKline) - Incorrect Labeling (2022)

Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

FDAMay 13, 2022Nationwide• GlaxoSmithKline LLC

Childrens Dimetapp Cold & Cough (Glaxosmithkline) – Defective Dosing Cup (2020)

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Class IIModerate

FDAJun 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Childrens Robitussin Honey Cough (Glaxosmithkline) – Defective Dosing Cup (2020)

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Class IIModerate

FDAJun 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Gaviscon Liquid Antacid (GSK) – Labeling Warning (2020)

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Class IIModerate

FDAMay 28, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Gaviscon Liquid Antacid (GSK) – Labeling Warning (2020)

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Class IIModerate

FDAMay 28, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Gaviscon Liquid Antacid (GSK) – Labeling Warning (2020)

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Class IIModerate

FDAMay 28, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Gaviscon Liquid Antacid (GSK) – Labeling Warning (2020)

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Class IIModerate

FDAMay 28, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Benefiber Healthy Shape (GSK) – Plastic Contamination (2020)

Fiber prebiotic product potentially contaminated with small plastic pieces

Class IIModerate

FDAApr 28, 2020AR, CA, FL +22 more• Glaxosmithkline Consumer Healthcare Holdings

Benefiber Prebiotic Fiber (GSK) – Plastic Contamination (2020)

Fiber prebiotic product potentially contaminated with small plastic pieces

Class IIModerate

FDAApr 28, 2020AR, CA, FL +22 more• Glaxosmithkline Consumer Healthcare Holdings

ChapStick Moisture + Tint (GSK) – Packaging Separation (2020)

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

FDAApr 20, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

ChapStick Moisture + Tint (GSK) – Packaging Separation (2020)

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

FDAApr 20, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

ChapStick Moisture + Tint (GSK) – Packaging Separation (2020)

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

FDAApr 20, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Ibuprofen Combination Tablets (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