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GlaxoSmithKline Recalls
23 recalls on record · July 18, 2012 to June 12, 2024 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 12, 2024DrugsFDA
GlaxoSmithKline LLC recalls Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 table
Hazard: 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.
January 3, 2024DrugsFDA
GlaxoSmithKline LLC recalls ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters
Hazard: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
June 1, 2022DrugsFDA
GlaxoSmithKline LLC recalls Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 497
Hazard: 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.
May 31, 2017DrugsFDA
GlaxoSmithKline, LLC recalls Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx on
Hazard: Defective Delivery System: Elevated number of units with out of specification results for leak rate
April 12, 2017DrugsFDA
GlaxoSmithKline, LLC recalls Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhaler
Hazard: Defective Delivery System: Elevated number of units with out of specification results for leak rate.
July 27, 2016DrugsFDA
GlaxoSmithKline, LLC recalls Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709,
Hazard: Penicillin Cross Contamination
July 27, 2016DrugsFDA
GlaxoSmithKline, LLC recalls Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle P
Hazard: Penicillin Cross Contamination
July 27, 2016DrugsFDA
GlaxoSmithKline, LLC recalls Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709,
Hazard: Penicillin Cross Contamination
July 27, 2016DrugsFDA
GlaxoSmithKline, LLC recalls Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709
Hazard: Penicillin Cross Contamination
December 16, 2015DrugsFDA
GlaxoSmithKline, LLC recalls Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral I
Hazard: Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
September 2, 2015DrugsFDA
GlaxoSmithKline, LLC. recalls Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Gla
Hazard: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
September 2, 2015DrugsFDA
GlaxoSmithKline, LLC. recalls Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manuf
Hazard: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
September 2, 2015DrugsFDA
GlaxoSmithKline, LLC. recalls Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Bar
Hazard: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
September 2, 2015DrugsFDA
GlaxoSmithKline, LLC. recalls Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road
Hazard: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
January 1, 2014DrugsFDA
GlaxoSmithKline, LLC. recalls Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges
Hazard: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
January 1, 2014DrugsFDA
GlaxoSmithKline, LLC. recalls Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containin
Hazard: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
November 20, 2013Medical DevicesFDA
GlaxoSmithKline, LLC. recalls Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened w
Hazard: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
August 14, 2013DrugsFDA
GlaxoSmithKline, LLC. recalls TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp,
Hazard: Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
December 5, 2012DrugsFDA
GlaxoSmithKline, LLC. recalls Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle
Hazard: Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
December 5, 2012DrugsFDA
GlaxoSmithKline, LLC. recalls Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, R
Hazard: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
December 5, 2012DrugsFDA
GlaxoSmithKline, LLC. recalls Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Or
Hazard: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
September 5, 2012DrugsFDA
GlaxoSmithKline Inc recalls Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION
Hazard: Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
July 18, 2012DrugsFDA
GlaxoSmithKline Inc recalls Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV
Hazard: Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.