Glaxosmithkline recalls

Glaxosmithkline appears in 23 official U.S. recall notices indexed by RecallRadar, most recently on 2024-06-12.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosin…
  FDA Drug · Class III · 2024-06-12 · Glaxosmithkline
  Reason: 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.
• ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Man…
  FDA Drug · Class III · 2024-01-03 · Glaxosmithkline
  Reason: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
• Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13
  FDA Drug · Class III · 2022-06-01 · Glaxosmithkline
  Reason: 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.
• Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline…
  FDA Drug · Class II · 2017-05-31 · Glaxosmithkline
  Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate
• Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSm…
  FDA Drug · Class II · 2017-04-12 · Glaxosmithkline
  Reason: Defective Delivery System: Elevated number of units with out of specification results for leak rate.
• Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, N…
  FDA Drug · Class II · 2016-07-27 · Glaxosmithkline
  Reason: Penicillin Cross Contamination
• Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, N…
  FDA Drug · Class II · 2016-07-27 · Glaxosmithkline
  Reason: Penicillin Cross Contamination
• Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC…
  FDA Drug · Class II · 2016-07-27 · Glaxosmithkline
  Reason: Penicillin Cross Contamination
• Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC…
  FDA Drug · Class II · 2016-07-27 · Glaxosmithkline
  Reason: Penicillin Cross Contamination
• Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net…
  FDA Drug · Class II · 2015-12-16 · Glaxosmithkline
  Reason: Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
• Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Op…
  FDA Drug · Class II · 2015-09-02 · Glaxosmithkline
  Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
• Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for…
  FDA Drug · Class II · 2015-09-02 · Glaxosmithkline
  Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
• Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Lt…
  FDA Drug · Class II · 2015-09-02 · Glaxosmithkline
  Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
• Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, U…
  FDA Drug · Class II · 2015-09-02 · Glaxosmithkline
  Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
• Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumat…
  FDA Drug · Class II · 2014-01-01 · Glaxosmithkline
  Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
• Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatript…
  FDA Drug · Class II · 2014-01-01 · Glaxosmithkline
  Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
• Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sor…
  FDA Device · Class II · 2013-11-20 · Glaxosmithkline
  Reason: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
• TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135…
  FDA Drug · Class III · 2013-08-14 · Glaxosmithkline
  Reason: Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
• Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKl…
  FDA Drug · Class III · 2012-12-05 · Glaxosmithkline
  Reason: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
• Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709
  FDA Drug · Class II · 2012-12-05 · Glaxosmithkline
  Reason: Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
• Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with…
  FDA Drug · Class III · 2012-12-05 · Glaxosmithkline
  Reason: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
• Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with…
  FDA Drug · Class II · 2012-09-05 · Glaxosmithkline
  Reason: Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
• Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Researc…
  FDA Drug · Class II · 2012-07-18 · Glaxosmithkline
  Reason: Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.