GlaxoSmithKline, LLC. FDA Record
GlaxoSmithKline, LLC. has 23 FDA recalls, 28 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GlaxoSmithKline, LLC." is on file.
- Latest recall
- D-0544-2024 · Class III · May 17, 2024
- Latest inspection
- Jul 15, 2026 · VAI
Reviewing GlaxoSmithKline, LLC. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check GlaxoSmithKline, LLC. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 23 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 28 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 2 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 1 | 0 |
| 2023 | 1 | 0 | 0 | 1 | 0 |
| 2022 | 0 | 0 | 0 | 1 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 2 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0544-2024 | Class III | Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains… | May 17, 2024 |
| D-0160-2024 | Class III | ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30… | Dec 12, 2023 |
| D-0896-2022 | Class III | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare… | May 13, 2022 |
| D-0793-2017 | Class II | Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt… | May 16, 2017 |
| D-0626-2017 | Class II | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations… | Mar 22, 2017 |
| D-1442-2016 | Class II | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research… | Jul 18, 2016 |
| D-1443-2016 | Class II | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research… | Jul 18, 2016 |
| D-1445-2016 | Class II | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research… | Jul 18, 2016 |
| D-1444-2016 | Class II | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline… | Jul 18, 2016 |
| D-0519-2016 | Class II | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations… | Dec 3, 2015 |
| D-1361-2015 | Class II | Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC… | Aug 13, 2015 |
| D-1362-2015 | Class II | Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only… | Aug 13, 2015 |
| D-1359-2015 | Class II | Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations… | Aug 13, 2015 |
| D-1360-2015 | Class II | Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK… | Aug 13, 2015 |
| D-387-2014 | Class II | Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe… | Nov 6, 2013 |
| D-388-2014 | Class II | Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2… | Nov 6, 2013 |
| Z-0272-2014 | Class II | Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ… | Oct 17, 2013 |
| D-850-2013 | Class III | TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets… | Jul 18, 2013 |
| D-065-2013 | Class III | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST… | Oct 24, 2012 |
| D-064-2013 | Class III | Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120… | Oct 24, 2012 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 15, 2026 | Conshohocken, PA | Drugs | Voluntary Action Indicated (VAI) | 3004055938 |
| Feb 20, 2026 | Zebulon, NC | Drugs | No Action Indicated (NAI) | 1033964 |
| Aug 16, 2024 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Apr 19, 2024 | Zebulon, NC | Drugs | Voluntary Action Indicated (VAI) | 1033964 |
| Jun 20, 2023 | Conshohocken, PA | Drugs | No Action Indicated (NAI) | 3004055938 |
| Sep 12, 2019 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Jan 26, 2018 | Zebulon, NC | Drugs | No Action Indicated (NAI) | 1033964 |
| Jan 26, 2018 | Conshohocken, PA | Drugs | Voluntary Action Indicated (VAI) | 3004055938 |
| Jul 15, 2016 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Apr 21, 2016 | Zebulon, NC | Drugs | Voluntary Action Indicated (VAI) | 1033964 |
| Aug 21, 2015 | Zebulon, NC | Drugs | No Action Indicated (NAI) | 1033964 |
| May 8, 2015 | Conshohocken, PA | Drugs | No Action Indicated (NAI) | 3004055938 |
| Apr 10, 2015 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Sep 29, 2014 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Aug 23, 2013 | King Of Prussia, PA | Drugs | Voluntary Action Indicated (VAI) | 1000522100 |
| May 3, 2013 | Zebulon, NC | Drugs | No Action Indicated (NAI) | 1033964 |
| Feb 5, 2013 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Jan 31, 2013 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Dec 19, 2012 | Durham, NC | Drugs | No Action Indicated (NAI) | 1035048 |
| Jun 7, 2011 | Conshohocken, PA | Drugs | No Action Indicated (NAI) | 3004055938 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004055938 | Conshohocken, PA | 5 | Jul 15, 2026 |
| FEI 1033964 | Zebulon, NC | 9 | Feb 20, 2026 |
| FEI 1035048 | Durham, NC | 11 | Aug 16, 2024 |
| FEI 1000522100 | King Of Prussia, PA | 1 | Aug 23, 2013 |
| FEI 3008320249 | Uxbridge, United Kingdom | 1 | May 14, 2010 |
| FEI 3004533187 | Marly Le Roi, France | 1 | Jun 12, 2009 |
GlaxoSmithKline, LLC. and the FDA: common questions
Has GlaxoSmithKline, LLC. received an FDA warning letter?
No FDA warning letter addressed to the name "GlaxoSmithKline, LLC." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has GlaxoSmithKline, LLC. received an FDA Form 483?
FDA has not published a Form 483 for "GlaxoSmithKline, LLC." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect GlaxoSmithKline, LLC.?
The most recent FDA inspection on file ended Jul 15, 2026 at Conshohocken, PA and was classified VAI. FDA has 28 inspections of GlaxoSmithKline, LLC. on file.
Has GlaxoSmithKline, LLC. had an FDA recall?
Yes. GlaxoSmithKline, LLC. has 23 FDA recalls on record. The most recent started May 17, 2024.
Need more than this page shows? Ask about GlaxoSmithKline, LLC. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.