The Recall Desk

Manufacturer

GlaxoSmithKline, LLC.

21 recalls in our database name GlaxoSmithKline, LLC. as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
11
Most recent
2024-06-12

Of the 21 recalls from GlaxoSmithKline, LLC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (52%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • ModerateFDA (Drugs)·D-0544-2024·2024-06-12

    TIVICAY HIV medication carton mislabeled with incorrect expiration date

    GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.

    Product
    TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0160-2024·2024-01-03

    Anoro Ellipta inhalation powder recalled for failed release testing defect

    GlaxoSmithKline is recalling 67,508 Anoro Ellipta inhalers nationwide because coarse particle mass failed release testing and was found out of specification. No illnesses have been reported.

    Product
    ANORO ELLIPTA — ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0896-2022·2022-06-01

    Drug Recall: Tivicay Tablets with Incorrect Expiration Date on Label

    GlaxoSmithKline is recalling 328 bottles of Tivicay (dolutegravir) tablets nationwide due to incorrect expiration date labeling. The label shows January 2027 but the correct expiration date is September 2026.

    Product
    TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1444-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Nasal Ointment Due to Penicillin Contamination

    GlaxoSmithKline is recalling Bactroban Nasal ointment tubes due to penicillin cross-contamination. The recall covers 153,119 units distributed nationwide and in Puerto Rico.

    Product
    Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1443-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Cross Contamination

    GlaxoSmithKline is recalling Bactroban Cream (Mupirocin Calcium Cream 2%) due to penicillin cross-contamination. The recall covers 7,480 tubes distributed nationwide and in Puerto Rico.

    Product
    Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1445-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination

    GlaxoSmithKline is recalling 18,000 tubes of Bactroban Ointment because of penicillin cross-contamination. The affected product is distributed nationwide and in Puerto Rico.

    Product
    Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1442-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Cross Contamination

    GlaxoSmithKline is recalling Bactroban Cream (Mupirocin Calcium Cream 2%) due to penicillin cross contamination. The recall affects 28,131 tubes distributed nationwide and in Puerto Rico.

    Product
    Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1359-2015·2015-09-02

    Bactroban Nasal Ointment Recalled for Penicillin Contamination

    GlaxoSmithKline is recalling Bactroban Nasal Ointment due to penicillin cross-contamination and foreign substances found during manufacturing.

    Product
    Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1361-2015·2015-09-02

    GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Contamination

    GlaxoSmithKline is recalling Bactroban Cream (mupirocin calcium) 2% because the product was contaminated with penicillin and foreign substances during manufacturing.

    Product
    Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1360-2015·2015-09-02

    Bactroban Ointment Recalled for Penicillin Contamination and Foreign Substances

    GlaxoSmithKline is recalling Bactroban Ointment due to penicillin cross-contamination and foreign substances found during manufacturing.

    Product
    Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1362-2015·2015-09-02

    GlaxoSmithKline Recalls Mupirocin Calcium Cream Due to Penicillin Contamination

    GlaxoSmithKline is recalling Mupirocin Calcium Cream, 2%, because the product was contaminated with penicillin and foreign substances during manufacturing.

    Product
    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 Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-387-2014·2014-01-01

    FDA Recalls Imitrex STATdose Systems Due to Sterility Concerns

    GlaxoSmithKline is recalling 10,469 Imitrex STATdose Systems because some syringes may have needles protruding through the shield, compromising sterility.

    Product
    IMITREX — IMITREX (SUMATRIPTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-388-2014·2014-01-01

    GlaxoSmithKline Recalls Sumatriptan Injection Cartridges Due to Sterility Concerns

    GlaxoSmithKline is recalling 9,743 cartridges of Sumatriptan Succinate Injection because some may have needles protruding through the shield, compromising sterility.

    Product
    Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Sing
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0272-2014·2013-11-20

    Biotene Moisturizing Mouth Spray Recalled for Incorrect Ingredient Labeling

    GlaxoSmithKline is recalling Biotene Moisturizing Mouth Spray because the label lists sorbitol, but the product does not contain it.

    Product
    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-068-2013·2012-12-05

    GlaxoSmithKline Recalls Arranon Injection Due to Potential Impurities

    GlaxoSmithKline is recalling specific lots of Arranon (nelarabine) Injection because drug-related impurities may exceed specification limits.

    Product
    Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-064-2013·2012-12-05

    GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues

    GlaxoSmithKline is recalling specific lots of Advair HFA inhalers because they failed to meet particle size distribution specifications.

    Product
    ADVAIR HFA — ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-065-2013·2012-12-05

    GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues

    GlaxoSmithKline is recalling 18,676 units of Advair HFA inhalers because they failed to meet particle size distribution specifications.

    Product
    ADVAIR HFA — ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

GlaxoSmithKline

company in Tokyo, Japan

Country
Japan
Founded
1953
Parent company
GSK

Official website

Source: Wikidata (Q43896200), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.