Glutathione: where it stands with the FDA, and what it costs
Often sold beside NAD+. No FDA-approved injectable drug contains it.
Prices by form:injections (221)nasal spray (29)troches (7)
Go to clinicLowest per monthGlutathione
Gatlan · from $39/mo (supply not stated, counted as 4 weeks: ≈ $42 per 30 days)
Go to clinicLowest at a clinic we link toGlutathione injection (30ml)
Affinity Direct · $98.88/mo
Where Glutathione stands today
No FDA-approved drug has glutathione as its active ingredient (an approved ophthalmic irrigation solution, BSS PLUS, contains glutathione disulfide, the oxidized form, as one of several components). FDA lists glutathione in 503A Category 1 and 503B Category 1, the nominated substances it is still evaluating, where it does not intend to take action if the conditions in its guidance are met; one of those conditions is that the bulk substance comes from an FDA-registered manufacturer with a valid certificate of analysis. FDA's advisory committee voted 8-5 (1 abstention) in June 2022 to recommend adding it to the 503A bulks list, against FDA's proposal; no rule has followed. USP's glutathione monograph is a dietary-supplement monograph, which FDA says does not count for 503A. In August 2026 FDA warned compounders not to use dietary-supplement-grade glutathione for injectables after at least 30 patients had adverse events, and several compounded glutathione injections were recalled in 2026 (three Class I) for endotoxin.
For pharmacies compounding one patient's prescription (section 503A)
Category 1 (Bulk Drug Substances Under Evaluation): FDA does not intend to take action against 503A compounding with it while it is evaluated, if the guidance's conditions are met. Not on the 503A bulks list.
“503A Category 1 – Bulk Drug Substances Under Evaluation ... Glutathione”
What Category 1 means (FDA 503A page)
“FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met.”
USP's glutathione monograph is a dietary-supplement monograph, so it does not make glutathione eligible on its own
“Accordingly, FDA does not consider USP monographs for dietary supplements to be applicable USP or NF monographs within the meaning of section 503A(b)(1)(A)(i)(I).”
USP's glutathione monograph sits in its Dietary Supplement Monographs
“Dietary Supplement Monographs, Glutathione”
For outsourcing facilities (section 503B)
Category 1 (Bulk Drug Substances Under Evaluation); not on the 503B bulks list.
“503B Category 1: Bulk Drug Substances Under Evaluation ... Glutathione”
What 503B Category 1 means
“FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances identified in category 1 provided that the conditions described in the guidance document are met.”
The FDA's compounding advisory committee
8 June 2022: Should glutathione be placed on the 503A bulks list?. Vote: Yes 8, No 5, Abstain 1. Committee recommended listing, against FDA's proposal; FDA has published no rule since, and glutathione remains in 503A Category 1
“2. VOTE: FDA is proposing that glutathione NOT be included on the 503A Bulks List. Should glutathione be placed on the list? Vote Result: Yes: 8 No: 5 Abstain: 1 Committee Discussion: A majority of committee members voted in favor of adding glutathione to the 503A Bulks List.”
FDA warnings, recalls and letters
2 April 2025: Warning letter on sterile-manufacturing (CGMP) failures; cites a glutathione 200 mg/mL lot left out of an environmental-monitoring investigation. (Empower Clinic Services, LLC dba Empower Pharma (registered 503B outsourcing facility), Houston, TX).
“For example, your firm did not include injectable drug product Glutathione 200mg/mL, lot (b)(4) ; however this lot was manufactured on August 16, 2023.”
20 January 2026: Same letter; glutathione products cited only for missing label statements. (GenoGenix LLC, Boca Raton, FL (registered 503B outsourcing facility)).
“Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.”
7 April 2026: Warning letter; NAD (1200 mg) and glutathione (2000 mg) injections cited for missing required label statements. (ProRx LLC (registered 503B outsourcing facility)).
“Some of your facility’s drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, Glutathione Injection 2000mg, and Tirzepatide Injection 45mg/2.5mL, did not include the following statement on the label: the statement “Not for Resale” (section 503B(a)(10)(A)(iii)(IX)).”
5 August 2026: Class I recall (D-0772-2026, classified 2026-08-19) of compounded glutathione 200 mg/mL vials for elevated endotoxin; company announcement published by FDA 2026-08-05. (Victory Medical Center Pharmacy, Austin, TX).
“The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels”
27 August 2026: FDA reminds compounders not to use dietary-supplement-grade glutathione for injectables: at least 30 patients had adverse events after IV glutathione made from Medisca lot #229536. (Compounders (FDA statement)).
“[8/27/2026] FDA is aware of reports of at least 30 patients who experienced adverse events following the administration of intravenous (IV) glutathione alone or in combination with other ingredients. ... The glutathione was labeled as dietary supplement grade, which is not an appropriate ingredient to make injectable drugs.”
13 September 2026: Recall of glutathione, Myers' Cocktail and Tri-Immune Boost vials made with a glutathione API with elevated endotoxin (company release 9/9/2026; FDA published 2026-09-13; not yet classified in openFDA). (Centric Compounding LLC, Houston, TX).
“The products have been found to be compounded with a Glutathione API containing elevated endotoxin levels”
16 September 2026: Class I recall of glutathione 200 mg/mL vials for bacterial endotoxin out of specification; initiated 2026-08-05, classified 2026-09-16. (Optimal Balance Pharmacy).
“Glutathione 200 mg/mL, 30 mL sterile multidose vial ... Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.”
1 October 2026: Recall of compounded glutathione for potential elevated endotoxin (company announcement 2026-10-01; openFDA D-0084-2027, Class I, classified 2026-10-27). (Greenwich Rx (503A pharmacy)).
“The product is being recalled due to potential elevated endotoxin levels.”
For athletes who are tested
Glutathione itself is not named on the WADA list; IV infusions or injections over 100 mL per 12 hours are a prohibited method (M2.2) outside hospital care (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026)).
“Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations.”
Our reading
A 503A pharmacy may compound glutathione (injection, IV, nasal, oral) for a patient-specific prescription, and a 503B facility may make it, under FDA's Category 1 policies, but only from pharmaceutical-grade bulk from a 510-registered manufacturer with a valid certificate of analysis; supplement-grade ingredient falls outside the policy (see actions).
Every source above was checked again on 14 November 2026.
What 259 clinics charge
- GatlanGlutathionefrom $39/mosupply not stated, counted as 4 weeks: ≈ $42 per 30 days
- PepScribeGlutathionefrom $49/mo
- Tonik WellnessGlutathionefrom $57/mo
- GoProLeanGlutathione injection$57.32/mo
- Nex Gen Health RxGlutathione injectionfrom $57.32/mo
What Glutathione is
- What it is
- Tripeptide antioxidant
- How it works
- A three-amino-acid antioxidant the body makes itself.
- How it is given
- Intramuscular or intravenous injection; also sold orally and as nasal sprays
- Also called
- L-glutathione, reduced glutathione
Glutathione side by side
About Glutathione
Is Glutathione FDA-approved?
No. No FDA-approved drug contains Glutathione. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is Glutathione legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug has glutathione as its active ingredient (an approved ophthalmic irrigation solution, BSS PLUS, contains glutathione disulfide, the oxidized form, as one of several components). FDA lists glutathione in 503A Category 1 and 503B Category 1, the nominated substances it is still evaluating, where it does not intend to take action if the conditions in its guidance are met; one of those conditions is that the bulk substance comes from an FDA-registered manufacturer with a valid certificate of analysis. FDA's advisory committee voted 8-5 (1 abstention) in June 2022 to recommend adding it to the 503A bulks list, against FDA's proposal; no rule has followed. USP's glutathione monograph is a dietary-supplement monograph, which FDA says does not count for 503A. In August 2026 FDA warned compounders not to use dietary-supplement-grade glutathione for injectables after at least 30 patients had adverse events, and several compounded glutathione injections were recalled in 2026 (three Class I) for endotoxin.
How much does Glutathione cost?
259 clinics publish a price. The lowest that compares per month is from $39/mo at Gatlan, and the middle of 203 clinics' lowest monthly prices is about $129. What a month buys differs by clinic, so each price lists what it includes. every Glutathione price
What forms does Glutathione come in?
Clinics sell it as injection (221 prices), other (45 prices), nasal spray (29 prices), troches (7 prices), patch (3 prices), capsules (2 prices), tablets (1 price).