{"shortAnswer":"Glutathione is in Category 1: pharmacies may use it while FDA decides, which is not approval. It is also sold as a dietary supplement. The evidence grade is limited-human: small trials with mixed results, and FDA reports of harm from tainted drips.","url":"https://peptideindex.ai/compound/glutathione","status":"category-1","statusCheckedAt":"2026-10-26T13:36:28.632Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T20:24:56.431Z","primarySourceUrl":"https://www.fda.gov/media/94155/download","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"5c4ae158-070b-4486-9c52-818e742e29dc","object":"compound","slug":"glutathione","name":"Glutathione","attrs":{"name":"Glutathione","pcac":{"vote":{"no":5,"yes":8,"abstain":1},"outcome":"The committee recommended adding glutathione to the 503A bulks list, against FDA's proposal to leave it off","meeting_date":"2022-06-08","indication_reviewed":"Skin lightening and more than 20 other uses, including lung disease, Parkinson's disease, autism and heavy metal poisoning"},"class":"other","access":[{"type":"dietary-supplement","detail":"Sold as a dietary supplement. FDA calls glutathione a dietary ingredient, and one maker told FDA it sells it in the US only for supplements.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"type":"lawful-compounding","detail":"A pharmacy may compound glutathione because it is in Category 1. FDA does not intend to act against it when the policy conditions are met. That is not FDA approval.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"type":"clinical-trial","detail":"Trials of glutathione are recruiting in the US, for example a nasal spray in Parkinson's disease. The trials block lists open trials.","source_url":"https://clinicaltrials.gov/study/NCT05266417"}],"trials":[{"nct":"NCT06340633","url":"https://clinicaltrials.gov/study/NCT06340633","phase":"Phase 2","title":"SPI-1005 in Adults Receiving Cochlear Implant","status":"recruiting","sponsor":"Sound Pharmaceuticals, Incorporated","countries":["United States"],"us_states":["Iowa","Ohio","Pennsylvania","South Carolina","Texas","Wisconsin"]},{"nct":"NCT07833865","url":"https://clinicaltrials.gov/study/NCT07833865","phase":"Not applicable","title":"The Effect of Light Therapy on Cellular Energy and Oxidative Stress in Healthy Adults and Type 1 Diabetic Patients","status":"not-yet-recruiting","sponsor":"University of Thi-Qar","countries":["Iraq"],"us_states":[]},{"nct":"NCT06260566","url":"https://clinicaltrials.gov/study/NCT06260566","phase":"Phase 1","title":"Tolerability of Enteral NAC in Infants","status":"not-yet-recruiting","sponsor":"Sanjiv Harpavat","countries":[],"us_states":[]},{"nct":"NCT07543458","url":"https://clinicaltrials.gov/study/NCT07543458","phase":"Phase 3","title":"Therapeutics for Moderate and Severe Dengue","status":"not-yet-recruiting","sponsor":"Oxford University Clinical Research Unit, Vietnam","countries":["Bangladesh","Brazil","Colombia","Indonesia","Malaysia","Nepal","Peru","Philippines","Thailand","Vietnam"],"us_states":[]},{"nct":"NCT07792369","url":"https://clinicaltrials.gov/study/NCT07792369","phase":"Phase 1","title":"26DT052; Scaling Busulfan Dose to Body Surface Area in Children","status":"not-yet-recruiting","sponsor":"Children's Hospital of Philadelphia","countries":["United States"],"us_states":["Pennsylvania"]},{"nct":"NCT07856381","url":"https://clinicaltrials.gov/study/NCT07856381","phase":"Not stated","title":"Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia","status":"recruiting","sponsor":"Medical University Innsbruck","countries":["Austria"],"us_states":[]},{"nct":"NCT07690124","url":"https://clinicaltrials.gov/study/NCT07690124","phase":"Not applicable","title":"S-Acetyl Glutathione and Performance Recovery in Soccer","status":"not-yet-recruiting","sponsor":"University of Thessaly","countries":["Greece"],"us_states":[]},{"nct":"NCT07622316","url":"https://clinicaltrials.gov/study/NCT07622316","phase":"Phase 1","title":"GAIP ASD Research Study","status":"recruiting","sponsor":"Greater Atlanta Integrative Pediatrics","countries":["United States"],"us_states":["Georgia"]},{"nct":"NCT07572890","url":"https://clinicaltrials.gov/study/NCT07572890","phase":"Phase 1","title":"Adia Med of Winter Park LLC Chronic Kidney Disease Research Study","status":"recruiting","sponsor":"Adia Med of Winter Park LLC","countries":["United States"],"us_states":["Florida"]},{"nct":"NCT07304440","url":"https://clinicaltrials.gov/study/NCT07304440","phase":"Phase 1","title":"Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study","status":"recruiting","sponsor":"Adia Med of Winter Park LLC","countries":["United States"],"us_states":["Florida","Wisconsin"]},{"nct":"NCT07050173","url":"https://clinicaltrials.gov/study/NCT07050173","phase":"Phase 1","title":"Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation","status":"recruiting","sponsor":"Pravat Mandal","countries":["United States"],"us_states":["Pennsylvania"]},{"nct":"NCT07064005","url":"https://clinicaltrials.gov/study/NCT07064005","phase":"Phase 1","title":"Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.","status":"recruiting","sponsor":"Pravat Mandal","countries":["United States"],"us_states":["Pennsylvania"]},{"nct":"NCT07448415","url":"https://clinicaltrials.gov/study/NCT07448415","phase":"Phase 2/Phase 3","title":"Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma","status":"not-yet-recruiting","sponsor":"Assiut University","countries":[],"us_states":[]},{"nct":"NCT07379216","url":"https://clinicaltrials.gov/study/NCT07379216","phase":"Not applicable","title":"Efficacy Evaluation Study of Vitamin C and Glutathione Liquid Sachet","status":"recruiting","sponsor":"TCI Co., Ltd.","countries":["Taiwan"],"us_states":[]},{"nct":"NCT07634991","url":"https://clinicaltrials.gov/study/NCT07634991","phase":"Phase 4","title":"To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy","status":"recruiting","sponsor":"Ain Shams University","countries":["Egypt"],"us_states":[]},{"nct":"NCT07314359","url":"https://clinicaltrials.gov/study/NCT07314359","phase":"Not applicable","title":"Rapid Effects of a Biofield Patch on Antioxidant Status and Cellular Energy","status":"recruiting","sponsor":"Natural Immune Systems Inc","countries":["United States"],"us_states":["Oregon"]},{"nct":"NCT07595705","url":"https://clinicaltrials.gov/study/NCT07595705","phase":"Phase 2","title":"Gingival Hyperpigmentation Treatment","status":"recruiting","sponsor":"Cairo University","countries":["Egypt"],"us_states":[]},{"nct":"NCT06922669","url":"https://clinicaltrials.gov/study/NCT06922669","phase":"Not applicable","title":"Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia","status":"recruiting","sponsor":"General Hospital of Shenyang Military Region","countries":["China"],"us_states":[]},{"nct":"NCT06896422","url":"https://clinicaltrials.gov/study/NCT06896422","phase":"Phase 1","title":"Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC","status":"recruiting","sponsor":"The First Affiliated Hospital of Zhengzhou University","countries":["China"],"us_states":[]},{"nct":"NCT06213857","url":"https://clinicaltrials.gov/study/NCT06213857","phase":"Phase 2","title":"Beneficial Effect of Silymarin in Ulcerative Colitis","status":"recruiting","sponsor":"Tanta University","countries":["Egypt"],"us_states":[]},{"nct":"NCT06957808","url":"https://clinicaltrials.gov/study/NCT06957808","phase":"Not applicable","title":"Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia","status":"recruiting","sponsor":"King's College London","countries":["United Kingdom"],"us_states":[]},{"nct":"NCT07202156","url":"https://clinicaltrials.gov/study/NCT07202156","phase":"Not applicable","title":"Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma","status":"recruiting","sponsor":"The First Affiliated Hospital with Nanjing Medical University","countries":["China"],"us_states":[]},{"nct":"NCT06554392","url":"https://clinicaltrials.gov/study/NCT06554392","phase":"Not stated","title":"Identification of Serum Level of Glutathione Peroxidase 4","status":"not-yet-recruiting","sponsor":"Assiut University","countries":[],"us_states":[]},{"nct":"NCT06620523","url":"https://clinicaltrials.gov/study/NCT06620523","phase":"Phase 2","title":"Prevent Cardiac Surgery Associated AKI Trial","status":"recruiting","sponsor":"George Washington University","countries":["United States"],"us_states":["District of Columbia"]},{"nct":"NCT06354712","url":"https://clinicaltrials.gov/study/NCT06354712","phase":"Phase 2","title":"Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.","status":"recruiting","sponsor":"Mansoura University","countries":["Egypt"],"us_states":[]},{"nct":"NCT05241262","url":"https://clinicaltrials.gov/study/NCT05241262","phase":"Phase 1","title":"Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels","status":"recruiting","sponsor":"Michio Hirano, MD","countries":["United States"],"us_states":["New York"]},{"nct":"NCT05654922","url":"https://clinicaltrials.gov/study/NCT05654922","phase":"Phase 3","title":"Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant","status":"recruiting","sponsor":"Renovion, Inc.","countries":["United States"],"us_states":["Arizona","California","Florida","Illinois","Iowa","Maryland","Minnesota","Missouri","New York","Ohio","Pennsylvania","South Carolina","Tennessee","Texas","Virginia"]},{"nct":"NCT05689645","url":"https://clinicaltrials.gov/study/NCT05689645","phase":"Phase 2","title":"F573 for Injection for the Treatment of Liver Injury/Failure","status":"recruiting","sponsor":"Beijing Continent Pharmaceutical Co, Ltd.","countries":["China"],"us_states":[]},{"nct":"NCT05266417","url":"https://clinicaltrials.gov/study/NCT05266417","phase":"Phase 2","title":"Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease","status":"recruiting","sponsor":"Gateway Institute for Brain Research","countries":["United States"],"us_states":["Florida"]}],"aliases":["L-glutathione"],"summary":"A substance sold in the US for use in dietary supplements. Pharmacies also make it into shots and drips into a vein.","citations":[{"n":1,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list, updated May 2026"},{"n":2,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":3,"url":"https://www.fda.gov/media/94164/download","tier":"primary","type":"regulatory","title":"FDA: 503B bulk drug substances category list, updated March 2025"},{"n":4,"url":"https://www.fda.gov/media/161293/download","tier":"primary","type":"regulatory","title":"FDA: Pharmacy Compounding Advisory Committee summary minutes, 8 June 2022"},{"n":5,"url":"https://www.fda.gov/media/159041/download","tier":"primary","type":"regulatory","title":"FDA: Pharmacy Compounding Advisory Committee questions, 8 June 2022"},{"n":6,"url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables","tier":"primary","type":"regulatory","title":"FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019"},{"n":7,"url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables","tier":"primary","type":"regulatory","title":"FDA compounding alert: supplement-grade glutathione not for injectables, August 2026"},{"n":8,"url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels","tier":"primary","type":"regulatory","title":"FDA-posted recall notice: compounded glutathione shots, possible high endotoxin, October 2026"},{"n":9,"url":"https://www.fda.gov/food/dietary-supplements","tier":"primary","type":"regulatory","title":"FDA: dietary supplements"},{"n":10,"url":"https://www.fda.gov/food/dietary-supplements/new-dietary-ingredient-ndi-notification-process","tier":"primary","type":"regulatory","title":"FDA: new dietary ingredient notification process"},{"n":11,"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances that may present significant safety risks"},{"n":12,"url":"https://www.bipc.com/navigating-the-fda-final-interim-policy-on-compounding-with-bulk-drug-substances-a-guide-for-503a-pharmacies-and-503b-outsourcing-facilities","tier":"legal-analysis","type":"legal-analysis","title":"Buchanan Ingersoll & Rooney: guide to FDA's interim policy on bulk drug substances"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/24791752/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: oral glutathione and body stores in healthy adults, 2015"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/39444151/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: glutathione for skin lightening and melasma, 2025"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/30895708/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: glutathione and skin color, 2019"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/28436395/","tier":"peer-reviewed","type":"rct","title":"Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/19230029/","tier":"peer-reviewed","type":"rct","title":"Pilot randomized trial: intravenous glutathione in Parkinson's disease, 2009"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/23240940/","tier":"peer-reviewed","type":"human-trial","title":"Survey: safety of intranasal glutathione as reported by users, 2013"},{"n":19,"url":"https://clinicaltrials.gov/study/NCT05266417","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT05266417: intranasal insulin and glutathione in Parkinson's disease"},{"n":20,"url":"https://clinicaltrials.gov/study/NCT06620523","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT06620523: oral glutathione to prevent kidney injury after heart surgery"},{"n":21,"url":"https://clinicaltrials.gov/study/NCT06896422","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT06896422: glutathione with immunotherapy and chemotherapy in lung cancer"},{"n":22,"url":"https://www.newsweek.com/at-home-iv-recall-warns-of-potentially-fatal-endotoxin-risk-12436818","tier":"established-news","type":"reference","title":"Newsweek: recall of at-home IV vials for endotoxin risk, 2026"}],"known_risks":["In August 2026, FDA reported at least 30 patients harmed after glutathione drips made from a supplement-grade ingredient. Some went to the hospital [^7].","The harms matched poisoning by endotoxin, a toxin from bacteria. Endotoxin can cause fever, chills, low blood pressure, shock and death [^6] [^7].","In 2019, FDA reported seven clinic patients who fell ill within minutes of glutathione drips. One went to the hospital [^6].","In October 2026, a pharmacy recalled glutathione shots that may hold too much endotoxin. Two patients went to the ER after it was put in a vein [^8].","In a trial of a nasal spray, one person given glutathione got a heart muscle disease [^16].","A 2025 skin review advised against glutathione drips, because of harms and no clear benefit [^14]."],"short_answer":"Glutathione is in Category 1: pharmacies may use it while FDA decides, which is not approval. It is also sold as a dietary supplement. The evidence grade is limited-human: small trials with mixed results, and FDA reports of harm from tainted drips.","evidence_grade":"limited-human","open_questions":["Nobody knows if raising glutathione levels with pills prevents any disease. The pill trial measured levels in the blood, not health [^13].","Nobody knows if pills or creams lighten skin for good. Reviews call the studies few and of mixed quality [^14] [^15].","It is not settled whether nasal glutathione helps Parkinson's disease. The trial authors call for larger and longer trials [^16].","FDA has not yet decided whether to add glutathione to the federal list, years after the 2022 committee vote [^1] [^4]."],"section_routes":"FDA's committee papers say glutathione is not part of any FDA-approved drug [^4]. The legal ways to get it are as a dietary supplement, from a pharmacy that compounds it, or in a clinical trial [^1] [^6].\n\nGlutathione pills and powders are sold as dietary supplements [^6] [^15]. FDA does not approve a supplement before it is sold, and the maker is responsible for its safety [^9].\n\nA prescriber can order glutathione made by a pharmacy, because it is in Category 1 [^1] [^2]. That is not FDA approval [^2]. FDA has told pharmacies not to make shots from supplement-grade glutathione [^7].\n\nTrials are testing glutathione in the US, for example as a nasal spray in Parkinson's disease and as a pill before heart surgery [^19] [^20]. The trials block on this page lists open trials with their dates.","status_by_route":[{"route":"Compounded by a pharmacy, such as shots, drips and nasal sprays","status":"category-1","source_url":"https://www.fda.gov/media/94155/download"},{"route":"Sold as an ingredient in dietary supplements","status":"dietary-supplement","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"}],"regulatory_as_of":"2026-10-26","section_channels":"Glutathione drips and shots reach people through clinics, drip bars and home delivery [^6] [^22]. Compounding pharmacies make these products [^7] [^8].\n\nThe main documented harm is endotoxin, a toxin from bacteria, in products made from supplement-grade glutathione [^6] [^7]. In 2019, FDA reported seven clinic patients who fell ill within minutes of a drip [^6]. In August 2026, FDA reported at least 30 patients harmed, some in the hospital [^7]. FDA knew of two Texas pharmacies that recalled glutathione shots for high endotoxin [^7]. A news report described a recall of drip vials sent to patients' homes [^22].\n\nFDA says supplement-grade ingredients are not fit for shots and may carry endotoxin [^7]. FDA has told compounders not to use them for shots [^6] [^7].","section_evidence":"The evidence grade is limited-human: there are a few small human trials, and their results are mixed [^13] [^14] [^16] [^17].\n\nBy mouth: in a six-month trial in 54 healthy adults, glutathione pills raised glutathione levels in the blood [^13]. Levels fell back a month after people stopped [^13]. The trial did not test whether people got healthier [^13].\n\nSkin lightening: a 2025 review found that pills and creams lightened skin in small trials [^14]. About half the studies had a high risk of bias, and the review said the gains do not last [^14]. A 2019 review of four studies called the evidence inconclusive [^15]. The 2025 review advised against drips for skin lightening [^14].\n\nParkinson's disease: in a 2017 trial of 45 people, a nasal spray did no better than a salt-water spray over three months [^16]. In a 2009 pilot trial of 21 people, drips into a vein did no better than a dummy drip [^17].\n\nAntioxidant claims: the pill trial saw a drop in one blood marker of oxidative stress [^13]. It did not show that this prevents disease [^13]. A 2013 survey of nasal spray users relied on their own reports, with no comparison group [^18].","regulatory_status":"category-1","section_what_it_is":"Glutathione is a small molecule the body makes. It is a chain of three amino acids, so it is a very short peptide [^16]. Cells use it to fight oxidative stress, a kind of chemical damage [^13]. Levels fall early in Parkinson's disease, which is one reason researchers test it [^16].\n\nIt is sold in several forms. Pills and powders are sold as dietary supplements [^6] [^15]. Pharmacies make it as shots, drips into a vein and nasal sprays [^7] [^18]. Creams are tested for skin lightening [^14]. A result for one form does not carry over to another [^14] [^15].\n\nThe body making glutathione does not mean that taking more of it helps. That is a separate question, and the evidence is mixed [^13] [^15].","section_is_it_legal":"Glutathione is in Category 1: FDA's list of substances pharmacies may use while FDA decides whether to add them to the federal list [^1] [^2]. That is not approval, and FDA is still deciding [^1] [^2]. Checked 26 October 2026.\n\nFor Category 1, FDA says it does not plan to act against a pharmacy that meets the policy's conditions [^2]. That is a choice not to act, not approval of glutathione as a drug [^2]. Glutathione is also in Category 1 on FDA's list for outsourcing facilities, which make larger batches [^3]. It is not in Category 2, FDA's list of substances that may present significant safety risks [^1] [^11].\n\nOn 8 June 2022, FDA's Pharmacy Compounding Advisory Committee reviewed glutathione for skin lightening and more than 20 other uses [^4] [^5]. FDA proposed leaving it off the federal list. The committee voted 8 to 5, with 1 abstaining, to add it [^4]. The committee gives advice only, and FDA decides by writing a rule [^2] [^12]. FDA's May 2026 list still shows glutathione in Category 1 [^1].\n\nAs a supplement, glutathione falls under a different law. FDA calls it a dietary ingredient, and one maker told FDA it sells it in the US only for supplements [^6]. FDA does not approve a dietary supplement before it is sold. The maker is responsible for its safety and label [^9] [^10].","unofficial_channels":[{"type":"compounding-outside-the-rules","what_it_is":"Glutathione shots and drips that pharmacies make from supplement-grade powder, which is not meant for injection.","enforcement":[{"date":"2026-08-27","text":"FDA compounding alert: compounders should not use supplement-grade glutathione to make injectable drugs, after reports of at least 30 harmed patients.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables"},{"date":"2026-10-01","text":"Recall notice posted by FDA: a 503A compounding pharmacy recalled glutathione shots for possible high endotoxin.","source_url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels"}],"legal_position":{"text":"FDA says compounders must use ingredients fit for injection, and should not use supplement-grade ingredients to make shots.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables"},"documented_risks":[{"text":"FDA reported at least 30 patients harmed after drips made from one supplement-grade lot of glutathione. Some went to the hospital.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables"},{"text":"A pharmacy recalled glutathione shots for possible high endotoxin after two patients needed emergency care.","source_url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels"}]},{"type":"clinic-or-med-spa","what_it_is":"Clinics, med spas and drip bars that give glutathione by drip into a vein, often for skin or general wellness.","enforcement":[{"date":"2019-06-07","text":"FDA compounding alert: drips made from a dietary-ingredient glutathione powder carried too much endotoxin and harmed clinic patients.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"}],"legal_position":{"text":"A clinic's glutathione drip is a compounded drug. Category 1 lets a pharmacy use glutathione under FDA's conditions, which is not approval.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},"documented_risks":[{"text":"Seven patients at an outpatient clinic fell ill within minutes of glutathione drips. One went to the hospital.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"text":"A 2025 skin review advised against glutathione drips for skin lightening, because of harms and no clear benefit.","source_url":"https://pubmed.ncbi.nlm.nih.gov/39444151/"}]}]},"provenance":{"name":{"fact_id":"3d535adb-8c6d-48bf-b36c-79f03b1ab9cb","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.660Z","confidence":1,"stale":false},"pcac":{"fact_id":"fd85990a-aa5a-421c-ab1c-f20cc54e627c","source_url":"https://www.fda.gov/media/161293/download","source_type":"primary","captured_at":"2026-10-26T08:31:42.290Z","checked_at":"2026-10-26T20:24:56.431Z","confidence":1,"stale":false},"class":{"fact_id":"4acd0241-e530-422c-9d64-27bec33310a7","source_url":"https://pubmed.ncbi.nlm.nih.gov/28436395/","source_type":"peer-reviewed","captured_at":"2026-10-26T08:31:46.049Z","checked_at":"2026-10-26T13:36:28.622Z","confidence":1,"stale":false},"access":{"fact_id":"8f145229-2c8f-4802-a581-c43b768c1aec","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.607Z","confidence":1,"stale":false},"trials":{"fact_id":"1ee89ce5-665a-4640-8db6-ff92a4c36b72","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=glutathione&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","source_type":"primary","captured_at":"2026-10-26T13:36:48.819Z","checked_at":"2026-10-26T13:36:48.819Z","confidence":1,"stale":false},"aliases":{"fact_id":"676897fb-0f37-4c96-8849-3e7ed7bb3279","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables","source_type":"primary","captured_at":"2026-10-26T08:30:46.107Z","checked_at":"2026-10-26T13:36:28.617Z","confidence":1,"stale":false},"summary":{"fact_id":"1020a9eb-b7e1-41ef-82d9-7253c56935a1","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables","source_type":"primary","captured_at":"2026-10-26T08:30:46.107Z","checked_at":"2026-10-26T13:36:28.647Z","confidence":1,"stale":false},"citations":{"fact_id":"1a1e49ed-0dbf-4ddd-a1a2-f1bc214f82d4","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.663Z","confidence":1,"stale":false},"known_risks":{"fact_id":"9877707c-e81d-4d5c-aa21-f3535a7d7f65","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables","source_type":"primary","captured_at":"2026-10-26T08:30:46.039Z","checked_at":"2026-10-26T13:36:28.678Z","confidence":1,"stale":false},"short_answer":{"fact_id":"863a71c4-33d9-4e3e-ae3a-c4a04406d32f","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-26T13:36:28.666Z","confidence":1,"stale":false,"label":"our assessment"},"evidence_grade":{"fact_id":"461b8973-2c80-4bc6-869e-4811374abb1b","source_url":"https://peptideindex.ai/methodology#evidence-grade","source_type":"reference","captured_at":"2026-10-25T00:14:45.193Z","checked_at":"2026-10-26T13:36:28.668Z","confidence":1,"stale":false,"label":"our assessment"},"open_questions":{"fact_id":"a9523809-2230-48ff-87a2-2ab990a808de","source_url":"https://pubmed.ncbi.nlm.nih.gov/24791752/","source_type":"peer-reviewed","captured_at":"2026-10-26T08:31:45.297Z","checked_at":"2026-10-26T13:36:28.654Z","confidence":1,"stale":false},"section_routes":{"fact_id":"ef901c88-29a1-4d62-a86b-96faa3955393","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.673Z","confidence":1,"stale":false},"status_by_route":{"fact_id":"1854bacd-005e-4b2b-b7d8-231550b414a1","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.644Z","confidence":1,"stale":false},"regulatory_as_of":{"fact_id":"ef1040e4-350b-472d-bbbb-94253059e053","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.630Z","confidence":1,"stale":false},"section_channels":{"fact_id":"564b76df-beac-4135-a021-47aa15731186","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables","source_type":"primary","captured_at":"2026-10-26T08:30:46.039Z","checked_at":"2026-10-26T13:36:28.636Z","confidence":1,"stale":false},"section_evidence":{"fact_id":"c992635d-9d98-4681-aac1-4bad42778a22","source_url":"https://pubmed.ncbi.nlm.nih.gov/24791752/","source_type":"peer-reviewed","captured_at":"2026-10-26T08:31:45.297Z","checked_at":"2026-10-26T13:36:28.640Z","confidence":1,"stale":false},"regulatory_status":{"fact_id":"e84a3453-4efc-4462-937b-30530aad2d11","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.632Z","confidence":1,"stale":false},"section_what_it_is":{"fact_id":"367abc1d-8274-4677-9ab0-52e1d94bc9ad","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.657Z","confidence":1,"stale":false},"section_is_it_legal":{"fact_id":"03909f1e-f9bf-4b6c-af39-b9e4d0fb5d2b","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-26T06:06:47.298Z","checked_at":"2026-10-26T13:36:28.670Z","confidence":1,"stale":false},"unofficial_channels":{"fact_id":"00420b8e-0ed7-492a-8e71-135c9c076e6a","source_url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables","source_type":"primary","captured_at":"2026-10-26T08:30:46.039Z","checked_at":"2026-10-26T13:36:28.651Z","confidence":1,"stale":false}},"citationsBySection":{"known_risks":[{"n":7,"title":"FDA compounding alert: supplement-grade glutathione not for injectables, August 2026","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables"},{"n":6,"title":"FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"n":8,"title":"FDA-posted recall notice: compounded glutathione shots, possible high endotoxin, October 2026","url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels"},{"n":16,"title":"Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017","url":"https://pubmed.ncbi.nlm.nih.gov/28436395/"},{"n":14,"title":"Systematic review: glutathione for skin lightening and melasma, 2025","url":"https://pubmed.ncbi.nlm.nih.gov/39444151/"}],"open_questions":[{"n":13,"title":"Randomized trial: oral glutathione and body stores in healthy adults, 2015","url":"https://pubmed.ncbi.nlm.nih.gov/24791752/"},{"n":14,"title":"Systematic review: glutathione for skin lightening and melasma, 2025","url":"https://pubmed.ncbi.nlm.nih.gov/39444151/"},{"n":15,"title":"Systematic review: glutathione and skin color, 2019","url":"https://pubmed.ncbi.nlm.nih.gov/30895708/"},{"n":16,"title":"Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017","url":"https://pubmed.ncbi.nlm.nih.gov/28436395/"},{"n":1,"title":"FDA: 503A bulk drug substances category list, updated May 2026","url":"https://www.fda.gov/media/94155/download"},{"n":4,"title":"FDA: Pharmacy Compounding Advisory Committee summary minutes, 8 June 2022","url":"https://www.fda.gov/media/161293/download"}],"section_routes":[{"n":4,"title":"FDA: Pharmacy Compounding Advisory Committee summary minutes, 8 June 2022","url":"https://www.fda.gov/media/161293/download"},{"n":1,"title":"FDA: 503A bulk drug substances category list, updated May 2026","url":"https://www.fda.gov/media/94155/download"},{"n":6,"title":"FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"n":15,"title":"Systematic review: glutathione and skin color, 2019","url":"https://pubmed.ncbi.nlm.nih.gov/30895708/"},{"n":9,"title":"FDA: dietary supplements","url":"https://www.fda.gov/food/dietary-supplements"},{"n":2,"title":"FDA: bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"n":7,"title":"FDA compounding alert: supplement-grade glutathione not for injectables, August 2026","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables"},{"n":19,"title":"ClinicalTrials.gov NCT05266417: intranasal insulin and glutathione in Parkinson's disease","url":"https://clinicaltrials.gov/study/NCT05266417"},{"n":20,"title":"ClinicalTrials.gov NCT06620523: oral glutathione to prevent kidney injury after heart surgery","url":"https://clinicaltrials.gov/study/NCT06620523"}],"section_channels":[{"n":6,"title":"FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"n":22,"title":"Newsweek: recall of at-home IV vials for endotoxin risk, 2026","url":"https://www.newsweek.com/at-home-iv-recall-warns-of-potentially-fatal-endotoxin-risk-12436818"},{"n":7,"title":"FDA compounding alert: supplement-grade glutathione not for injectables, August 2026","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables"},{"n":8,"title":"FDA-posted recall notice: compounded glutathione shots, possible high endotoxin, October 2026","url":"https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels"}],"section_evidence":[{"n":13,"title":"Randomized trial: oral glutathione and body stores in healthy adults, 2015","url":"https://pubmed.ncbi.nlm.nih.gov/24791752/"},{"n":14,"title":"Systematic review: glutathione for skin lightening and melasma, 2025","url":"https://pubmed.ncbi.nlm.nih.gov/39444151/"},{"n":16,"title":"Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017","url":"https://pubmed.ncbi.nlm.nih.gov/28436395/"},{"n":17,"title":"Pilot randomized trial: intravenous glutathione in Parkinson's disease, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19230029/"},{"n":15,"title":"Systematic review: glutathione and skin color, 2019","url":"https://pubmed.ncbi.nlm.nih.gov/30895708/"},{"n":18,"title":"Survey: safety of intranasal glutathione as reported by users, 2013","url":"https://pubmed.ncbi.nlm.nih.gov/23240940/"}],"section_what_it_is":[{"n":16,"title":"Phase IIb trial: intranasal glutathione in Parkinson's disease, 2017","url":"https://pubmed.ncbi.nlm.nih.gov/28436395/"},{"n":13,"title":"Randomized trial: oral glutathione and body stores in healthy adults, 2015","url":"https://pubmed.ncbi.nlm.nih.gov/24791752/"},{"n":6,"title":"FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"n":15,"title":"Systematic review: glutathione and skin color, 2019","url":"https://pubmed.ncbi.nlm.nih.gov/30895708/"},{"n":7,"title":"FDA compounding alert: supplement-grade glutathione not for injectables, August 2026","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables"},{"n":18,"title":"Survey: safety of intranasal glutathione as reported by users, 2013","url":"https://pubmed.ncbi.nlm.nih.gov/23240940/"},{"n":14,"title":"Systematic review: glutathione for skin lightening and melasma, 2025","url":"https://pubmed.ncbi.nlm.nih.gov/39444151/"}],"section_is_it_legal":[{"n":1,"title":"FDA: 503A bulk drug substances category list, updated May 2026","url":"https://www.fda.gov/media/94155/download"},{"n":2,"title":"FDA: bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"n":3,"title":"FDA: 503B bulk drug substances category list, updated March 2025","url":"https://www.fda.gov/media/94164/download"},{"n":11,"title":"FDA: bulk drug substances that may present significant safety risks","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"n":4,"title":"FDA: Pharmacy Compounding Advisory Committee summary minutes, 8 June 2022","url":"https://www.fda.gov/media/161293/download"},{"n":5,"title":"FDA: Pharmacy Compounding Advisory Committee questions, 8 June 2022","url":"https://www.fda.gov/media/159041/download"},{"n":12,"title":"Buchanan Ingersoll & Rooney: guide to FDA's interim policy on bulk drug substances","url":"https://www.bipc.com/navigating-the-fda-final-interim-policy-on-compounding-with-bulk-drug-substances-a-guide-for-503a-pharmacies-and-503b-outsourcing-facilities"},{"n":6,"title":"FDA compounding alert: dietary ingredient glutathione in sterile injectables, June 2019","url":"https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables"},{"n":9,"title":"FDA: dietary supplements","url":"https://www.fda.gov/food/dietary-supplements"},{"n":10,"title":"FDA: new dietary ingredient notification process","url":"https://www.fda.gov/food/dietary-supplements/new-dietary-ingredient-ndi-notification-process"}]},"channelsOpener":"This section describes what happens and is not a recommendation.","sources":["https://clinicaltrials.gov/api/v2/studies?query.intr=glutathione&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","https://peptideindex.ai/methodology#evidence-grade","https://peptideindex.ai/methodology#short-answer","https://pubmed.ncbi.nlm.nih.gov/24791752/","https://pubmed.ncbi.nlm.nih.gov/28436395/","https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables","https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables","https://www.fda.gov/media/161293/download","https://www.fda.gov/media/94155/download"],"verified_at":"2026-10-26T20:24:56.431Z","published_at":"2026-10-26T20:25:02.741Z","parent":null,"children":[],"snapshots":{"trials":{"snapshot_at":"2026-10-26T13:36:48.819Z","stale":false,"notice":"A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}