GlaxoSmithKline LLC Recalls

All product recalls associated with GlaxoSmithKline LLC.

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Recall Summary

Total Recalls

22

Past Year

0

Class I (Serious)

0

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 22 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.

Class IIILow

FDAMay 17, 2024Nationwide• GlaxoSmithKline LLC

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

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

Class IIILow

FDADec 12, 2023Nationwide• GlaxoSmithKline LLC

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

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

Class II

Moderate

FDADec 2, 2022Nationwide• GlaxoSmithKline Consumer Healthcare Holdings LLC

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

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.

Class IIILow

FDAMay 13, 2022Nationwide• GlaxoSmithKline LLC

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 Ointment (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Class IIModerate

FDAJul 18, 2016Nationwide• 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

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 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.

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.

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 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.

Imitrex STATdose System (GlaxoSmithKline) – needle shield issue (2013)

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

Class IIModerate

FDANov 6, 2013Nationwide• GlaxoSmithKline, LLC.

Sumatriptan Succinate Injection (GlaxoSmithKline) – sterility concern (2013)

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

Class IIModerate

FDANov 6, 2013Nationwide• GlaxoSmithKline, LLC.

TUMS Ultra (GlaxoSmithKline) – Foreign Tablets (2013)

Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets

Class IIILow

FDAJul 18, 2013Nationwide• GlaxoSmithKline, LLC.

Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Class IIILow

FDAOct 24, 2012Nationwide• GlaxoSmithKline, LLC.

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GlaxoSmithKline LLC Recalls

Recall Summary

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

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

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

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

Tivicay (GlaxoSmithKline) - Incorrect Labeling (2022)

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

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

Bactroban Ointment (GlaxoSmithKline) – Penicillin Contamination (2016)

Bactroban Nasal (GlaxoSmithKline) – Penicillin Contamination (2016)

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

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

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

Bactroban Ointment (GSK) – Contamination Risk (2015)

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

Bactroban Cream (GSK) – Contamination Risk (2015)

Imitrex STATdose System (GlaxoSmithKline) – needle shield issue (2013)

Sumatriptan Succinate Injection (GlaxoSmithKline) – sterility concern (2013)

TUMS Ultra (GlaxoSmithKline) – Foreign Tablets (2013)

Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)