Mitochondrial
Glutathione
- US status
- Compoundable (503A)
- Class
- Mitochondrial
- Approved product
- None
- Route
- Injection; IV infusion
Regulatory record
- August 2026
- Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
Every entry above is dated; the record is current as of the review date.
Definition
Glutathione is a tripeptide of glutamate, cysteine, and glycine, the body's most abundant intracellular antioxidant; it is synthesized in every cell rather than obtained primarily from outside.
The injectable market sells it chiefly for skin tone and general wellness, uses that sit far from the molecule's textbook biochemistry.
Evidence
Systematic reviews of glutathione for skin outcomes find limited, short-term, and mixed evidence: a 2019 review reported some skin-tone effects in small trials with oral and topical use, and a 2025 review in melasma reached guarded conclusions about efficacy and durability [1, 2]. Evidence specifically for intravenous or intramuscular glutathione is thinner than for the oral forms the reviews mostly cover.
No glutathione product is FDA-approved for cosmetic indications, and the trials that exist are small enough that a confident claim in either direction outruns the data.
The route is where the record thins to nothing. Searched in August 2026, the pairing of glutathione with skin lightening, whitening, bleaching, hyperpigmentation, or melanogenesis returns 206 indexed papers, of which 7 carry the clinical-trial publication type and 4 the randomized-controlled-trial type; narrowing the same search to records that also name an intravenous, intramuscular, injected, or injectable route returns 12 papers and no clinical trial of any kind [6].
All 7 clinical trials were read rather than counted. Six test an oral, buccal, or topical preparation: an eight-week open-label single-arm study of a glutathione lozenge in 30 Filipino women reported a fall in melanin index [3], and a double-blind randomized study in 46 participants compared topical and oral glutathione against each route alone [4]. The seventh is an injectable, and it is not a trial of this question: it tested a four-ingredient hyaluronate complex containing vitamin C, tranexamic acid, and glutathione in 120 patients with periorbital hyperpigmentation, which is a combination product for under-eye pigment rather than glutathione alone for skin tone [5, 6].
Safety is the thinner half of that record. A 2016 review found no study of intravenous glutathione for skin lightening and no study of its safety in long-term use for any indication; the intravenous trials in other conditions reported no or minimal adverse effects but lasted only a few doses [12]. A 2026 narrative review reached the same place a decade later, naming hepatotoxicity, hypersensitivity reactions and possible renal and endocrine effects as open safety concerns and judging the evidence too limited to justify routine cosmetic use [11].
Side effects
No controlled trial has characterized the safety of intravenous or intramuscular glutathione as it is sold for skin tone and wellness. A 2016 review found no study of intravenous glutathione for skin lightening and no study of its long-term safety for any indication; the short intravenous trials in other conditions reported no or minimal adverse effects [12]. A 2026 review lists hepatotoxicity, hypersensitivity reactions and possible renal and endocrine effects as unresolved concerns [11].
The best-documented harms come from contaminated ingredients rather than from the molecule. In 2019 the FDA reported nausea, vomiting, lightheadedness, chills, body aches and fever in patients given compounded intravenous glutathione made from a dietary-supplement powder, with two patients taken to hospital, and found excessive bacterial endotoxin in that powder [10]. More recently it reported at least 30 patients with fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, some hospitalized, after intravenous glutathione compounded from one lot of dietary supplement grade material [9].
Case reports show what can happen without establishing how often. A 2025 report describes shock, very high fever, liver injury and abnormal clotting within an hour of an unregulated glutathione infusion for skin lightening; the patient recovered, and the authors suspected endotoxin contamination [13]. The oral and topical forms that most skin trials tested are different exposures, and their results do not describe an infusion [1, 2].
Educational summary of the cited sources, not medical advice; a prescriber weighs these risks against a person’s own history.
Lawful access
Glutathione is listed in Category 1 of the FDA's interim 503A bulks list; licensed pharmacies may compound it with a valid prescription while review continues.
The injectable skin-whitening trade sits outside that route entirely, and the federal record of it is dated. A consent decree of permanent injunction was entered in the United States District Court for the District of New Jersey on September 26, 2017 in United States v. Flawless Beauty LLC, a case the FDA still cites by number in its own correspondence [7]; under that decree the company announced on January 18, 2018 a recall of nineteen products, and the announcement the FDA republished states that all of the glutathione products were sold in multi-vial whitening kits, alone or with ampules of vitamin C and sterile water [8]. That action is a dated public record and nothing more; it says nothing about any other seller.
The FDA's most recent warnings concern the ingredient rather than the indication. In June 2019 the agency reported adverse events in patients given intravenous glutathione compounded from a powder labeled as a dietary supplement, and its laboratory found excessive bacterial endotoxin in samples of that powder [10]. On August 27, 2026 it reported at least 30 patients with adverse events after intravenous glutathione compounded by different pharmacies from a single lot of dietary supplement grade glutathione, and reminded compounders not to use dietary supplement grade ingredients in injectable drugs [9]. A single case report from 2025 describes systemic inflammatory response syndrome within an hour of an unregulated glutathione infusion given for skin lightening [13].
Supply
Partner programs; this reference earns a commission on starts. Details.
- Visit bmiMD (opens in a new tab)
bmiMDPartnerForm: InjectionBasis: Compounded
Publishes a glutathione injection alongside its peptide and longevity treatments, prescribed after an online medical questionnaire.
- Visit Bodybuilding Health+ (opens in a new tab)
Bodybuilding Health+PartnerForm: InjectionBasis: Compounded
Publishes a glutathione injection under a heading of advanced peptide therapies, prescribed after a provider-guided intake.
- Visit Direct Meds (opens in a new tab)
Direct MedsPartnerForm: Weekly injectionBasis: CompoundedNo price published
Publishes glutathione as a once-weekly injection, compounded in the United States; the page prints no price.
- Visit Eden (opens in a new tab)
EdenPartnerForm: InjectionBasis: CompoundedFrom $95 first month, plus a $99 monthly membership after month one
Publishes compounded glutathione injections prescribed after a virtual visit, and states that an active membership is required on top of the medication price.
- Visit HealthRX (opens in a new tab)
HealthRXPartnerForm: InjectionBasis: Compounded$152 billed monthly
Publishes a compounded sterile glutathione injection at 200 mg/mL, with a provider reviewing each request before a pharmacy dispenses.
- Visit Live Vital (opens in a new tab)
Live VitalPartnerForm: Injection · oralBasis: Compounded$99 a month on a 3-month protocol
Publishes physician-prescribed glutathione delivered by injection or in a liposomal oral form.
- Visit RxSpan MD (opens in a new tab)
RxSpan MDPartnerForm: InjectionBasis: CompoundedFrom $109
Lists a glutathione injection on its products page.
- Visit ShedRx (opens in a new tab)
ShedRxPartnerForm: InjectionBasis: CompoundedFrom $119 a month
Publishes glutathione injections as its own product and describes the preparation as compounded.
Show all 9 suppliersShow fewer
- Visit System Labs (opens in a new tab)
System LabsPartnerForm: Injection · nasal sprayBasis: Compounded$149 a month injection, $169 nasal spray
Publishes glutathione as a monthly injection supply and as a nasal spray, as separate treatments.
Every finding was read in September 2026; tap a seller to see it. Prices are each seller’s own published figure, in its own unit. Order is alphabetical, not a ranking.
Questions
Is glutathione FDA-approved?
No glutathione product is FDA-approved for skin lightening or other cosmetic uses. Glutathione sits in Category 1 of the interim 503A bulks list, so a licensed pharmacy may compound it with a valid prescription while FDA review continues, as of September 2026.
Are glutathione injections legal in the US?
Yes, when a licensed pharmacy compounds them for a patient with a valid prescription. Compounded drugs are not reviewed by the FDA for safety or effectiveness, and injectable kits sold directly for skin whitening fall outside that route [7, 8].
What are the side effects of IV glutathione?
They are poorly documented, because no controlled trial has studied intravenous glutathione for skin or wellness use [12]. The FDA has reported fever, chills, dizziness and sepsis-like reactions linked to contaminated dietary supplement grade ingredient, and reviewers list liver injury and hypersensitivity as open concerns [9, 10, 11].
Does glutathione lighten skin?
The evidence is limited, short-term and mixed, and it comes mostly from oral and topical forms [1, 2]. No clinical trial has tested injected glutathione alone for skin tone [6]; the skin-lightening review reads each trial.
Why has the FDA warned about glutathione?
Because of ingredient quality. In 2019 and again in 2026 the FDA linked adverse reactions after intravenous glutathione to dietary supplement grade material with high endotoxin levels, and it has told compounders not to use such ingredients in injectable drugs [9, 10].
Elsewhere in this index
Filed under
- CompoundableCompoundable (503A)
- Mitochondrial4 molecules in this class
- The molecule indexEvery molecule, filterable by status and class
Evidence reviews
- Glutathione Injections for Skin LighteningIs injectable glutathione established for skin lightening, and what has the FDA said about it?
Reference tables
- The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
- The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
- The human trial record, by moleculeHow many human clinical trials exist for each peptide in this index?
- The WADA Prohibited ListWhich peptides in this index are prohibited in sport, and under which class?
Same class
- NAD+Compoundable (503A)
- MOTS-cPCAC-recommended · pending
- ElamipretideFDA-approved
References
- Dilokthornsakul W, Dhippayom T, Dilokthornsakul P. The clinical effect of glutathione on skin color and other related skin conditions: A systematic review. J Cosmet Dermatol. 2019 Jun;18(3):728-737. PMID 30895708
- Sarkar R, Yadav V, Yadav T, P J, Mandal I. Glutathione as a skin-lightening agent and in melasma: a systematic review. Int J Dermatol. 2025 Jun;64(6):992-1004. PMID 39444151
- Handog EB, Datuin MS, Singzon IA. An open-label, single-arm trial of the safety and efficacy of a novel preparation of glutathione as a skin-lightening agent in Filipino women. Int J Dermatol. 2016;55(2):153–157. PMID 26148180
- Wahab S, Anwar AI, Zainuddin AN, et al. Combination of topical and oral glutathione as a skin-whitening agent: a double-blind randomized controlled clinical trial. Int J Dermatol. 2021;60(8):1013–1018. PMID 33871071
- Guo F, Zhang Z, Su X, et al. Efficacy and safety of injectable sodium hyaluronate with vitamin C, tranexamic acid, and glutathione for pigmented dark circles. J Dermatolog Treat. 2025;36(1):2574306. PMID 41117156
- PubMed, National Library of Medicine. Census run August 2026. "glutathione" paired with "skin lightening" OR "skin whitening" OR "skin bleaching" OR "hyperpigmentation" OR "melanogenesis" returns 206 indexed records, 98 carrying the Humans MeSH term, 7 under "clinical trial"[Publication Type] and 4 under "randomized controlled trial"[Publication Type]; all 7 were read individually rather than counted, and 6 test an oral, buccal, or topical preparation while the seventh is an injectable four-ingredient hyaluronate complex for periorbital hyperpigmentation. Narrowing the same pairing to records that also name an intravenous, intramuscular, injection, or injectable route returns 12 records, 0 under the clinical-trial type and 0 under the randomized type. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type, the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored in the same run. Source
- US Food and Drug Administration. Warning letter to Flawless Beauty and Skin, CMS 630567, August 5, 2022, citing the Consent Decree of Permanent Injunction entered by the United States District Court on September 26, 2017 in United States v. Flawless Beauty LLC, et al., No. 17-7091 (D.N.J.). Read August 2026. Source
- US Food and Drug Administration. Company announcement republished by the FDA: Flawless Beauty, LLC issues voluntary recall of unapproved drugs. Company announcement date January 18, 2018; FDA publish date January 23, 2018. Read August 2026. Source
- US Food and Drug Administration. FDA reminds compounders not to use dietary supplement grade glutathione for injectables. August 27, 2026; content current as of August 27, 2026. Read September 2026. The page reports at least 30 patients with adverse events after intravenous glutathione, alone or with other ingredients, compounded by different pharmacies from one lot of glutathione labeled as dietary supplement grade; reported events included fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, some resulting in hospitalization, consistent with exposure to excessive endotoxin. Source
- US Food and Drug Administration. FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables. Compounding alert, June 7, 2019. Read September 2026. The alert describes adverse event reports in which patients given intravenous injections of compounded L-glutathione experienced nausea, vomiting, lightheadedness, chills, body aches, fever, with one patient transferred to a hospital and another admitted to one, and states that FDA laboratory testing found excessive bacterial endotoxin in samples of the dietary-supplement-labeled powder. Source
- Aloraini K, Alangari A, Arif J, Alkhodairy F. Glutathione for skin lightening via intravenous, oral, and topical routes: a critical narrative review of current evidence, safety, and the evidence-practice gap. J Med Life. 2026;19(7):511-523. PMID 42751591
- Davids LM, Van Wyk JC, Khumalo NP. Intravenous glutathione for skin lightening: inadequate safety data. S Afr Med J. 2016;106(8):782-786. PMID 27499402
- Sharma D, Daram S, Sharma P. Systemic inflammatory response syndrome following high-dose intravenous glutathione-containing revitalising solution in a patient on tirzepatide: a case report. Cureus. 2025;17(5):e84736. PMID 40556995