Article
Is injectable glutathione safe after the 2026 recalls? Only if your pharmacy can prove the ingredient was made for injection
This is for MDs, DOs, NPs, PAs, and the nurses who run injection and IV services in longevity, functional, aesthetic, and cash-pay clinics that stock glutathione. Since July 2026, CDC has counted more than 25 people in at least four states who got sick after glutathione injections, and four Texas pharmacies have recalled glutathione for endotoxin. Every product linked to those illnesses so far was compounded from glutathione sold as a dietary supplement ingredient. Whether injectable glutathione is safe in your clinic now depends on paperwork you can ask your pharmacy for today.
There is no FDA-approved glutathione drug in the United States, so every vial in your clinic is compounded. CDC advises clinics not to give injectable glutathione made from dietary supplement grade ingredient, or any product whose ingredient grade the pharmacy can't verify. Before the next dose, get the lot number, the name of the company that made the ingredient, and a written statement that it is suitable for injection. Match the route on the label, check every lot against the recalls, and keep emergency supplies in the room.
What happened with injectable glutathione in 2026?
In July 2026, the Texas Department of State Health Services told CDC about a group of patients who became sick after IV glutathione at an outpatient wellness clinic. As of CDC's September 15, 2026 update, more than 25 people in Texas, Washington, Florida, and New York had become ill. Patients received glutathione by IV, under the skin, or into a muscle. At least three were hospitalized, all after IV doses, and one needed intensive care for shock and abnormal blood clotting.
FDA traced the problem upstream. Its August 27 notice describes at least 30 patients with adverse events after IV glutathione, alone or mixed with other ingredients. Different pharmacies made those products, but all of them bought glutathione lot 229536 from Medisca Inc., and that lot was labeled dietary supplement grade. Medisca told FDA on August 20 that it had warned its U.S. customers not to use the ingredient in injectables.
| Date (2026) | What happened | Source |
|---|---|---|
| August 5 | Victory Medical Center Pharmacy in Austin recalls three lots of glutathione 200 mg/mL multi-dose vials for elevated endotoxin. Product went to consumers in Texas, Florida, and New York. | FDA recall notice |
| August 19 | Optimal Balance Pharmacy in Houston recalls one lot of glutathione 200 mg/mL, 30 mL vials, distributed in 14 states. | FDA recall notice |
| August 27 | FDA reminds compounders not to use dietary supplement grade glutathione in injectables and names Medisca lot 229536. | FDA |
| September 9 | Centric Compounding in Houston recalls six lots of glutathione, Myers' Cocktail, and Tri-Immune Boost made with a glutathione ingredient that had elevated endotoxin. | FDA recall notice |
| September 15 | CDC posts interim recommendations for clinics, pharmacies, and patients. | CDC |
| October 1 | Greenwich Rx in Tomball recalls lots of glutathione made for subcutaneous use after two patients needed emergency care following IV administration. | FDA recall notice |
| October 6 | QUAD A and MedSpa Board publish joint guidance on IV infusion safety in aesthetic and wellness practices. | Joint release |
Is glutathione FDA approved, and how do clinics get it?
No. CDC states plainly that there are no FDA-approved glutathione products in the United States. In the U.S. it is sold as an oral dietary supplement, so any injectable version is a compounded drug. FDA says compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness, or quality before they reach patients.
Glutathione is also not one of the six substances on FDA's final list of bulk ingredients that 503A pharmacies may use, found in 21 CFR 216.23. Pharmacies that compound it from bulk powder rely on FDA's interim policy for nominated bulk substances, which still requires a valid certificate of analysis and an FDA-registered manufacturer. Ask your pharmacy which policy it relies on for glutathione, and keep the answer in writing.
Why is dietary supplement grade glutathione a problem for injection?
FDA's position is that ingredients labeled for dietary supplement use may contain impurities and contaminants, including endotoxins, that can hurt patients when injected. Endotoxins come from the cell walls of certain bacteria. Killing the bacteria does not get rid of them, so a sterile solution can still carry enough endotoxin to cause fever and shock. Removing endotoxin takes much harsher conditions than sterilizing, such as dry heat at 250 °C.
This has happened before. In 2019, FDA warned compounders about glutathione powder repackaged by Letco Medical after seven patients at one outpatient clinic reacted to IV glutathione. FDA's lab found endotoxin as high as five times the appropriate limit, and the powder was labeled "Caution: Dietary Supplement." In Australia, a 2015 cluster of seven cases of probable endotoxin poisoning was traced to imported glutathione powder used by one Sydney compounding pharmacy. The vials grew no bacteria, yet every sample carried endotoxin above the safe threshold, and investigators concluded the powder was likely contaminated before it reached the pharmacy. Five of those patients were getting infusions for Lyme disease.
Why didn't a passing endotoxin test settle it?
The Greenwich Rx recall answers that. In its notice to the California State Board of Pharmacy, the pharmacy said each recalled lot was tested for bacterial endotoxins before release and all results met specifications. It recalled them anyway because the glutathione ingredient was labeled dietary supplement grade.
FDA tells compounders not to rely on testing alone and to build quality into ingredient sourcing, stock solution preparation, and release. For you, that means a clean test result on the finished vial does not answer the first question, which is what the ingredient was made for.
Does the route on the vial label matter?
Yes. Greenwich Rx made its recalled glutathione for subcutaneous injection, and its two reports involved patients who needed emergency department care after IV administration of a product not formulated for IV use. CDC's three hospitalized patients all received glutathione intravenously.
There is a mechanical reason the route matters. FDA notes that endotoxin limits should be calculated using the maximum dose intended for IV administration. A vial built and tested for a small subcutaneous dose was not checked against the dose a patient gets in a large IV push or drip. The accepted fever threshold is 5 endotoxin units per kilogram per hour, so a vial that passes at a small dose can exceed it at a large IV dose. If the label says subcutaneous or intramuscular, it is not an IV product. The QUAD A and MedSpa Board guidance says the same thing in general terms: don't give an IV therapy when the ingredients are not appropriate for the intended route.
What should you ask your pharmacy before the next glutathione order?
These questions come from CDC's recommendations for clinics and pharmacies and from FDA's notice. The last two are Scriptura recommendations.
- Was this lot compounded from an ingredient labeled dietary supplement or dietary supplement grade? CDC says not to give it if the answer is yes or unknown.
- Who made the glutathione ingredient? Ask for the original manufacturer, not only the repackager. FDA wants suppliers to name the upstream manufacturer on labels and certificates of analysis and state which uses the ingredient is and isn't suitable for.
- Can we see the certificate of analysis for the specific ingredient lot? CDC says it should list the tests, acceptance criteria, results, and methods, which can include identity, assay, purity, microbial limits, and bacterial endotoxin.
- Which route was this preparation made for, and what dose was the endotoxin limit calculated on?
- Is this a 503A prescription for a named patient, or 503B office stock? If 503B, is the facility on FDA's registered outsourcing facility list?
- What sterility and endotoxin testing was done on the finished lot, and what is the beyond-use date?
- How will you notify us of a recall, and who takes adverse event reports?
What should you do now if glutathione is already on your shelf?
Check every vial's lot number against the recalls below. CDC asks clinics to sequester any potentially implicated product, follow the pharmacy's return instructions, and contact patients who received affected product. Look past single-ingredient vials too. Centric's recall covered Myers' Cocktail and Tri-Immune Boost, so ask about any blend that contains glutathione.
| Pharmacy | Product | Lots | Distribution |
|---|---|---|---|
| Victory Medical Center Pharmacy (Austin, TX) | Glutathione 200 mg/mL multi-dose vials | 1980571, 1981940, 1984345 | Consumers in TX, FL, NY (notice) |
| Optimal Balance Pharmacy (Houston, TX) | Glutathione 200 mg/mL, 30 mL multi-dose vial | LG342009076 | 14 states listed in the notice |
| Centric Compounding (Houston, TX) | Glutathione 200 mg/mL 30 mL; Myers' Cocktail 30 mL; Tri-Immune Boost 30 mL | Glutathione 062326:B, 070826:A, 072726:D; Myers' 070226:D, 072126:A; Tri-Immune 071626:B | Nationwide, to patients and prescribers (notice) |
| Greenwich Rx (Tomball, TX) | Glutathione 200 mg/mL, 10 mL multi-dose vials for subcutaneous use | Lots beginning 0060-, full list in the notice | Nationwide, dispensed June 26 to September 21 (notice) |
| Medisca Inc. (ingredient supplier) | Dietary supplement grade glutathione bulk powder | 229536 | Sold to multiple compounding pharmacies (FDA) |
Report suspected reactions to FDA MedWatch, and report clusters to your state or local health department. CDC also asks that compounding quality concerns go to FDA and your state board of pharmacy. If you'd rather not check FDA and state notices by hand, Scriptura's regulatory monitoring runs a daily scan of FDA, Federal Register, and state board sources and tells the prescriber what changed.
How do you recognize an endotoxin reaction?
CDC lists fever, chills, myalgia, nausea, vomiting, hypotension, tachycardia, and injection-site reactions as signs to look for during or after an injection. FDA adds dizziness, signs of shock, and sepsis-like symptoms. In the Australian cluster, patients became symptomatic within two hours of their infusions. Teach staff that rigors in the chair are a reason to stop, not to slow the drip.
| What you see | Think about | First move |
|---|---|---|
| Fever, chills, rigors, body aches, headache, or nausea during or within hours of a dose | Endotoxin exposure (CDC) | Stop the infusion, keep IV access, check vitals, refer to the right level of care, save the vial with its lot number, report to the pharmacy and MedWatch |
| Low blood pressure, fast heart rate, confusion, or other signs of shock | Severe endotoxin reaction (FDA) | Stop the infusion, call 911, start your emergency protocol |
| Hives, wheeze, stridor, throat or tongue swelling, with or without low blood pressure | Anaphylaxis (WAO 2020) | Stop the infusion, give IM epinephrine in the anterolateral thigh, call 911 |
| Pain, swelling, or redness at a subcutaneous or IM site | Injection-site reaction or contamination (CDC) | Examine and document, check the lot, tell the pharmacy, report |
The World Allergy Organization's 2020 guidance gives epinephrine 0.01 mg/kg of 1 mg/mL solution, up to 0.5 mg, intramuscularly, repeated every 5 to 15 minutes if symptoms persist. Keep it in the room, with oxygen and IV supplies, every time glutathione is given.
Who should prescribe and monitor glutathione injections?
The October 6 joint guidance from QUAD A and MedSpa Board says IV infusions should be prescribed by a physician, PA, or APRN acting within their scope and state law. Licensed, credentialed staff should start the infusion and watch the patient for adverse events the whole time. The groups also say practices should not give an IV therapy if they can't verify the product's source or quality, or can't manage the complications they should expect.
State law sets the details, and boards are tightening them. Maine's Chapter 15 joint rule, in effect since July 14, 2026, requires an examination and diagnosis by a physician, physician associate, or APRN before any IV preparation and treats standing orders in IV businesses as unprofessional conduct. This outbreak started at a Texas wellness clinic. Scriptura's Texas rules page and state-by-state prescribing pages are a place to start on the prescribing side.
What does the evidence say glutathione injections actually do?
Less than most IV menus suggest. In a 2009 randomized, double-blind pilot, Hauser and colleagues gave 21 people with Parkinson's disease either IV glutathione 1,400 mg three times a week for four weeks or placebo. The infusions were well tolerated, but the trial found no significant symptom benefit.
For skin lightening, a 2025 narrative review summarizes a placebo-controlled trial of 1,200 mg IV glutathione twice a week for six weeks. In that trial, 6 of 16 women who finished glutathione reported lighter skin versus 3 of 16 on placebo, a difference that was not statistically significant, and only one kept the effect at six months. The authors reported side effects in every participant, and nine women on glutathione stopped early, eight for abnormal liver tests and one for anaphylactic shock. A 2025 systematic review concluded that IV glutathione should not be used for skin lightening because it does not work and causes side effects. The same review notes that the Philippine FDA has warned against IV glutathione for this use. The Australian cluster shows the other common reason patients ask for it, chronic Lyme disease. No randomized or controlled trial has tested injected glutathione for Lyme disease or post-treatment Lyme symptoms, and the investigators of the Australian cluster wrote that high-quality evidence for it does not exist.
Put that in your consent form: the drug is compounded, it is not FDA approved, the evidence for the reason the patient wants it is thin, and the known risks include endotoxin reactions from contaminated ingredient. CDC's patient guidance asks a fair question too: are there options that don't involve an injection?
Key takeaways
- No glutathione drug is FDA approved. Every injectable vial is compounded, and glutathione is not on FDA's final 503A bulks list.
- CDC has linked more than 25 illnesses in at least four states to injectable glutathione made from dietary supplement grade ingredient. FDA traced at least 30 adverse events to one Medisca lot.
- Four Texas pharmacies have recalled glutathione since August. Check your lots, including Myers' Cocktail and immune blends.
- A passing endotoxin test on the finished vial is not enough. Ask what the ingredient was made for and who made it.
- A vial labeled for subcutaneous use is not an IV product. All three hospitalized patients in CDC's count received IV doses.
- Fever, chills, and rigors after a dose mean stop, save the vial, and report.
Frequently asked questions
Is injectable glutathione FDA approved?
No. CDC says there are no FDA-approved glutathione products in the U.S. Clinics use compounded glutathione, which FDA does not review for safety or effectiveness before use.
Is IV glutathione safe?
It can be given more safely when the ingredient is made for injection, the vial is made for IV use, and a licensed clinician monitors the patient. The 2026 illnesses all involved dietary supplement grade ingredient.
What are the side effects of IV glutathione?
Reactions reported in 2026 include fever, chills, body aches, headache, nausea, dizziness, and low blood pressure, which match endotoxin exposure. In a skin-lightening trial, nine women on glutathione stopped early, eight for abnormal liver tests and one for anaphylactic shock. Case reports describe a shock-like inflammatory reaction within an hour of a high-dose product and Stevens-Johnson syndrome after a drip of glutathione with vitamins C and D. No study gives a rate for serious reactions, and no study has followed repeated IV glutathione beyond about 12 weeks.
Is a glutathione push safer than a drip?
We found no study comparing them. In trials that report a rate, IV glutathione was given over 10 to 15 minutes, for example 2,500 mg over 10 minutes before emergency angioplasty for heart attack and 1,500 mg/m² over 15 minutes before chemotherapy. What matters most is that the vial is made and tested for IV use at the dose you give.
Which glutathione lots are recalled?
Recalls cover lots from Victory Medical Center Pharmacy, Optimal Balance Pharmacy, Centric Compounding, and Greenwich Rx, plus Medisca ingredient lot 229536. Check FDA's recall notices for the full lists.
Where do I report a reaction to glutathione?
Report to FDA MedWatch and to the pharmacy. Report clusters to your state or local health department, and quality concerns to your state board of pharmacy.
What should a patient ask before a glutathione injection?
Ask whether it was made with an ingredient intended for injection, which pharmacy made it, whether that product is recalled, and what symptoms to watch for afterward.
Where does Scriptura fit?
Every glutathione decision above leaves a record: the pharmacy answers, the ingredient lot, the route, the dose, the reaction, the report. Scriptura is clinical decision-support software for licensed practitioners. It brings patient information, research, and regulatory updates, like CDC's glutathione recommendations and FDA recall notices, into one structured workflow and prepares clinician-reviewable plans with the reasoning written down. You review, edit, and sign every plan. Scriptura does not diagnose or prescribe. If injectable glutathione is on your audit list, request a Scriptura demo. License verification gets you platform access.
