REPORTED SIGNALS
glutathione
Registration status unknownSupplementlongevityDeseret Biologicals, Inc.
ORAL
USES: • For the temporary relief of symptoms including: • tingling in hands • tingling in feet • mood changes • frequent colds • poor digestion • fatigue • occasional constipation These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
2,108
reports (FAERS)
78.9%
reported as serious
133
fatal reports (6.3%)
25
signals above threshold
1981
first approved
2026-07
last updated
TIMELINE · FDA MILESTONES
Approved
1981
Class II recall
2025
Class II recall
2025
1980
2026
SIGNAL RANKING · ROR
What stands out in the reports.
On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Toxic Anterior Segment Syndrome
717.5 [560.8–918.0]
Corneal Oedema
230.4 [173.5–306.0]
Endophthalmitis
224.9 [187.3–269.9]
Hepatic Function Abnormal
30.1 [24.7–36.6]
Lymphocyte Count Decreased
28.7 [21.7–38.0]
Drug-induced Liver Injury
23.7 [18.7–30.1]
Neutrophil Count Decreased
13.6 [10.4–17.9]
Myelosuppression
13.2 [9.7–17.9]
Alanine Aminotransferase Increased
11.8 [9.3–15.0]
Aspartate Aminotransferase Increased
11.5 [8.9–14.9]
Platelet Count Decreased
9.4 [7.7–11.6]
Hypokalaemia
8.8 [6.4–12.1]
White Blood CELL Count Decreased
7.7 [6.1–9.6]
Anaemia
5.1 [4.2–6.3]
Chest Discomfort
3.9 [2.8–5.3]
ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.
INTERPRETATION
Auto-generated
Glutathione reports show several adverse effects more often than average. These include decreased platelet count, low potassium (hypokalaemia), and abnormal liver function. A very high signal for Toxic Anterior Segment Syndrome (TASS) is also present. Glutathione is an antioxidant, and these reported effects are not directly explained by its known action. It's important to remember that 'frequently reported' doesn't mean 'frequently caused'. Further investigation is needed to understand these signals. This does not replace medical advice.
This does not replace medical advice.
LABEL VERSUS REPORT
On the label
No signals currently mapped to the label.
Newly reported
Toxic Anterior Segment Syndrome
Corneal Oedema
Endophthalmitis
Hepatic Function Abnormal
Lymphocyte Count Decreased
Drug-induced Liver Injury
Neutrophil Count Decreased
Myelosuppression
REPORTS OVER TIME
Report volume per quarter.
19811982198319841986
RECALL HISTORY · 77 ON RECORD
| Date | Class | Reason | Firm |
|---|---|---|---|
| Jul 30, 2025 | II | Lack of Assurance of Sterility | GenoGenix LLC |
| Jul 30, 2025 | II | Lack of Assurance of Sterility | GenoGenix LLC |
| Dec 22, 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| May 9, 2022 | II | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 7, 2022 | II | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding |
| Mar 7, 2022 | II | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding |
| Aug 13, 2021 | II | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Aug 13, 2021 | II | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Jan 15, 2020 | II | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical |
| Sep 12, 2019 | II | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc |
| Aug 12, 2019 | II | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Aug 12, 2019 | II | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Aug 12, 2019 | II | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Jun 26, 2019 | II | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy |
| Jun 19, 2019 | II | Lack of Assurance of Sterility | RXQ Compounding LLC |
| Jun 19, 2019 | II | Lack of Assurance of Sterility | RXQ Compounding LLC |
| Apr 8, 2019 | II | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding |
| Jan 2, 2019 | II | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy |
| Jan 2, 2019 | II | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy |
| Dec 17, 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| Sep 10, 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| Aug 21, 2018 | II | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. |
| Jun 25, 2018 | II | Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. | La Vita Compounding Pharmacy, LLC |
| May 17, 2018 | II | Lack of sterility assurance. | Guardian Pharmacy Services |
| May 17, 2018 | II | Lack of sterility assurance. | Guardian Pharmacy Services |
| May 17, 2018 | II | Lack of sterility assurance. | Guardian Pharmacy Services |
| Mar 22, 2018 | II | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy |
| Jan 19, 2018 | II | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC |
| Jan 19, 2018 | II | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC |
| Jan 19, 2018 | II | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC |
| Jan 19, 2018 | II | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC |
| Jan 19, 2018 | II | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC |
| Aug 15, 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| Apr 18, 2017 | II | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center |
| Nov 17, 2016 | II | Lack of Assurance of Sterility | Tri-Coast Pharmacy |
| Sep 21, 2016 | II | Lack of Assurance of Sterility | Wells Pharmacy Network LLC |
| May 17, 2016 | II | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy |
| May 17, 2016 | II | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy |
| May 13, 2016 | II | Lack of Assurance of Sterility | Medaus, Inc. |
| Oct 19, 2015 | II | Lack of Assurance of Sterility | Western Drug |
| Oct 19, 2015 | II | Lack of Assurance of Sterility | Western Drug |
| Oct 16, 2015 | II | Lack of Assurance of Sterility | Downing Labs, LLC |
| Jul 24, 2015 | II | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy |
| Jul 24, 2015 | II | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy |
| Jun 2, 2015 | II | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America |
| Jun 2, 2015 | II | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America |
| May 18, 2015 | II | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. |
| May 15, 2015 | II | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy |
| May 15, 2015 | II | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy |
| Dec 12, 2014 | II | Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial. | Right Value Drug Stores, Inc. |
| Oct 6, 2014 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds |
| Oct 6, 2014 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds |
| Sep 5, 2014 | I | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile. | Pharmacy Creations |
| Jun 25, 2014 | II | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc |
| Apr 29, 2014 | II | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims. | Flawless Beauty LLC |
| Apr 29, 2014 | II | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. | Flawless Beauty LLC |
| Apr 29, 2014 | II | Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. | Flawless Beauty LLC |
| Nov 1, 2013 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center |
| Nov 1, 2013 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center |
| Oct 19, 2013 | II | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy |
| Aug 23, 2013 | II | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. | Medaus, Inc. |
| Aug 23, 2013 | II | Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory. | Creative Compounds |
| Aug 23, 2013 | II | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. | Wellness Pharmacy, Inc. |
| Jul 26, 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Beacon Hill Medical Pharmacy, P.C. |
| May 29, 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 28, 2013 | II | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Main Street Family Pharmacy, LLC |
| May 28, 2013 | II | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Main Street Family Pharmacy, LLC |
| May 28, 2013 | II | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Main Street Family Pharmacy, LLC |
| May 2, 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. |
| Apr 22, 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. |
| Apr 10, 2013 | II | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs |
| May 25, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| May 25, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm. Source: openFDA enforcement.
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SOURCE & CITATION
HealthProves. glutathione — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/glutathione/
FAERS2,108 records
Retrieved2026-07-04
MethodROR / disproportionality