More Than 25 People Sickened as Glutathione Injection Recalls Mount

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<p>On October 1, 2026, the FDA <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels">posted a notice</a> that a Texas pharmacy was recalling 10 lots of injectable glutathione because the vials may contain elevated levels of bacterial endotoxin (bacterial components that can trigger serious inflammatory reactions). The recall follows reports of two people requiring emergency department care and is the fourth involving a Texas pharmacy <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/amazon-acetaminophen-millions-of-eye-drops-compounded-glutathione/">in less than two months</a>.</p>
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<p>Greenwich Rx, a compounding pharmacy in Tomball, Texas, said the recalled injections were intended for subcutaneous use (under the skin), but the two people who required emergency care had received the product intravenously.</p>
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<p>In the recall notice, the company said: “injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death.”</p>
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<p>The recalled lots are: </p>
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<ul class="wp-block-list"><!-- wp:list-item -->
<li>0060-062426-1</li>
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<li>0060-062726-1</li>
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<li>0060-070926-1</li>
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<li>0060-071426-1 </li>
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<li>0060-071426-2 </li>
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<li>0060-072026-1 </li>
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<li>0060-072726-1 </li>
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<li>0060-072926-1 </li>
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<li>0060-073126-1 </li>
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<li>0060-080426-1 </li>
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<p>Anyone with a recalled vial should stop using it, the company said.</p>
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<h2 class="wp-block-heading">How Can Pharmacies Compound Glutathione Without FDA Approval?</h2>
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<p>Medical spas often promote glutathione “drips” for purported skin-rejuvenating and skin-lightening effects. However, no FDA-approved glutathione product exists, and high-quality studies have not shown that injected glutathione can lighten skin.</p>
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<p>Despite the lack of FDA approval, compounding pharmacies <a href="https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act">can still legally make and distribute</a> glutathione, along with certain peptides and other bulk substances, under specific conditions. Glutathione is among the bulk drug substances the FDA is evaluating for compounding use, and the agency's <a href="https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act">interim policy</a> generally allows qualifying pharmacies to continue compounding it while that review is underway.</p>
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<p>This regulatory loophole has led to an explosion in compounding pharmacy activity, which doctors say increases the risk of manufacturing lapses that create safety problems.</p>
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<p>“Now when we start talking about compounding pharmacies, the standards have changed. They’re not [well] regulated,” says <a href="https://health.usnews.com/doctors/nima-majlesi-645516">Nima Majlesi,</a> D.O.., director of medical toxicology at Staten Island University Hospital, Northwell Health. “So the risk then becomes you’re using something that could have contamination… [which] could have an adverse outcome.”</p>
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<p>The Greenwich Rx recall is the latest in a string of safety issues related to compounded </p>
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<p>medications. At least three other Texas pharmacies, Victory Medical Center Pharmacy, Optimal Balance Pharmacy and Centric Compounding, have recalled glutathione, according to the CDC.</p>
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<p>As of Sept. 15, the <a href="https://www.cdc.gov/healthcare-associated-infections/current-situation/index.html">CDC has received reports</a> of more than 25 people sickened in at least four states: Texas, Washington, Florida and New York. At least three were hospitalized. </p>
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<p>Earlier, in August, <a href="https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables">the FDA said</a> it had received reports of at least 30 people who experienced adverse events after receiving intravenous glutathione. The injections came from several compounding pharmacies, all of which sourced their glutathione from Medisca Inc. The ingredient was labeled for use in dietary supplements, not for injection.</p>
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<h2 class="wp-block-heading">Unsubstantiated Wellness Claims and Safety Concerns</h2>
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<p>Despite little convincing evidence that glutathione injections can lighten skin, the treatment has gained traction in the beauty and wellness industry, partly fueled by social media.</p>
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<p>“Trendiness on social media is definitely a driver for public interest,” says <a href="https://health.usnews.com/doctors/alexis-carrington-2554348">Alexis Carrington, M.D.</a>, a board-certified dermatologist in Washington, D.C. “Cultural beauty standards that favor lighter skin tones can also contribute to interest and can reinforce colorism. Patients should be cautious of marketing that promises dramatic or permanent results, particularly when those claims aren’t supported by strong clinical evidence.”</p>
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<p>Dr. Majlesi notes that glutathione’s popularity has also grown as doctors tout its antioxidant effects.</p>
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<p>“Glutathione is something that’s become popular in the past few years with all the biohacking and the alternative kind of medication industry kind of taking off,” he says. But “it’s probably [not] all that bioavailable to begin with. There are ways to boost your glutathione levels without actually injecting glutathione that are probably healthier.”</p>
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<p>Beyond the risk of contamination during manufacturing, it’s unclear whether injectable glutathione itself is safe because it has not been evaluated in high-quality studies.</p>
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<p>In theory, the drug should be relatively harmless if it were made in a properly equipped facility and given in a sterile environment, Dr. Majlesi says. However, Dr. Carrington notes there have been some <a href="https://academic.oup.com/jbcr/article-abstract/46/3/652/8064631?redirectedFrom=fulltext">case reports</a> suggesting possible injuries, including anaphylaxis and severe cutaneous adverse reactions <a href="https://medshadow.org/drug-updates-recalls/drug-safety/stevens-johnson-syndrome-symptoms-causes-treatment/">such as Stevens-Johnson syndrome</a>.</p>
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<p>“Even though these reports don’t determine how frequently these complications happen or prove that glutathione caused every case, it raises important safety concerns, especially when the treatment is being considered for cosmetic benefit,” Dr. Carrington says.</p>
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<h2 class="wp-block-heading">What To Ask Before Glutathione Treatment</h2>
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<p>People determined to visit medical spas should keep the risks in mind and ask questions before treatment, says <a href="https://www.mdcsnyc.com/provider/toral-vaidya-md-mph">Toral Vaidya, M.D</a>., a board-certified dermatologist in New York City.</p>
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<p>“People go to these med spas and think it’s like getting your hair or nails done, but there are so many other risks,” Dr. Vaidya says. “The biggest risk to having anything administered intravenously is that it may not be clinical grade, and you don’t know what pharmacy it came through.”</p>
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<p>Both Dr. Vaidya and Dr. Carrington agree that anyone visiting a medical spa should first ask exactly what ingredients are in the infusion; it could contain more than glutathione. Consumers should also ask whether a licensed physician is on site and whether a licensed pharmacy made the product. Consumers should disclose any medical conditions before the infusion and ask for an after-hours emergency number if something goes wrong, Dr. Vaidya adds. </p>
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<p>“Some emergent symptoms after an injection include difficulty breathing, fever, chills, swelling of the face or throat, fainting, or a severe or blistering rash. These should prompt urgent medical evaluation,” Dr. Carrington says.</p>
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<p>For people seeking glutathione injections for cosmetic or general wellness purposes, the potential risks may outweigh the unproven benefits, Dr. Majlesi says. “If there’s no evidence for benefit, then there’s only potential for risk.”</p>
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