FDA Recalls and Warnings: Glutathione Peptide Injections Recalled Over Endotoxin Contamination

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<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting drug recalls for compounded glutathione. </p>
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<p>The recall involving Victory Medical Center Pharmacy is a nationwide Class I recall, the most serious type. The recall involving Optimal Balance Pharmacy has not yet been classified, but because of its similarity to the Victory recall, it is likely to also be assigned a Class I level.</p>
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<p>Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall. </p>
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<h2 class="wp-block-heading">How To Read This Report</h2>
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<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or "not yet classified."</p>
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<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
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<li>Class I recalls are the most serious. In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death."</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<p>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.</p>
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<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99">unapproved new drugs</a>. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.</p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
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<h3 class="wp-block-heading">Compounded Glutathione</h3>
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<p><strong>Company</strong>: Victory Medical Center Pharmacy, a full-service pharmacy (fills regular and compounded prescriptions)   <br><strong>Manufacturing Location</strong>: Austin, Texas by Victory Medical Center Pharmacy; source of active ingredient not specified<br><strong>Scope</strong>: 91 multidose 200 mg/mL, 30 mL vials distributed to clinics and consumers in Texas, Florida, and New York.<br><strong>Drug Purpose</strong>: Compounded injectable glutathione is a type of peptide therapy marketed as a treatment to help fight cell damage, support the immune system, and support liver detoxification.<br><strong>Recall Reason</strong>: Microbial contamination risk; testing found elevated bacterial endotoxin levels. Injectable products with elevated endotoxin may cause fever, low blood pressure, inflammatory reactions, anaphylactic shock, or death.<br><strong>Recall Initiation Date</strong>: July 1, 2026 <br><strong>Recall Level</strong>: Class I<br><strong>Essential Extras</strong>: In a press release, Victory Medical Center Pharmacy states that it has received reports of adverse events including fever, chills, severe headache, nausea, vomiting, tachycardia, changes in blood pressure, body aches, and instances of injection site reactions. While the source of the endotoxin contamination has not been determined or disclosed, the FDA has had concerns for years about compounders using glutathione prepared for use in dietary supplements as an ingredient in injectable products. The FDA issued a <a href="https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables">warning</a> in 2019 to compounders about cases where patients were harmed by sterile injections made with the wrong type of glutathione. <a href="https://www.fda.gov/drugs/human-drug-compounding/fda-compounders-know-your-bulks-and-excipients-suppliers">FDA Guidance to Compounders</a> was released in February 2026, advising compounders to ensure that their suppliers test ingredients and properly label them to confirm quality and appropriate use.<br><strong>Link</strong>: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/victory-medical-center-pharmacy-issues-voluntary-nationwide-recall-certain-lots-compounded">FDA Press Release</a> and <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99509">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Compounded Glutathione Injection</h3>
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<p><strong>Company</strong>: Optimal Balance Pharmacy<br><strong>Manufacturing Location</strong>: Optimal Balance Pharmacy, Houston, Texas; source of active ingredient not specified<br><strong>Scope</strong>: 53 multidose 200 mg/mL, 30 mL vials. Distributed to consumers in Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont, and Washington.<br><strong>Drug Purpose</strong>: Compounded injectable glutathione is a type of peptide therapy marketed as a treatment to fight cell damage, support the immune system, and support liver detoxification. <br><strong>Recall Reason</strong>: Microbial contamination risk; testing found elevated bacterial endotoxin levels. Injectable products with elevated endotoxin may cause serious reactions including fever, low blood pressure, inflammatory reactions, anaphylactic shock, or death.<br><strong>Recall Initiation Date</strong>: August 5, 2026 <br><strong>Recall Leve</strong>l; Not yet classified, but will likely be classified as a Class I recall based on the severity of health risk.<br><strong>Essential Extras</strong>: In a press release, Optimal Balance Pharmacy says it has received reports of adverse events including fever, chills, severe headache, nausea, vomiting, pain, and symptoms consistent with an allergic reaction. While the source of the endotoxin contamination has not been determined or disclosed, the FDA has had concerns for years about compounders using glutathione prepared for use in dietary supplements as an ingredient in injectable products. The FDA issued a <a href="https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables">warning</a> in 2019 to compounders about cases where patients were harmed by sterile injections made with the wrong type of glutathione. <a href="https://www.fda.gov/drugs/human-drug-compounding/fda-compounders-know-your-bulks-and-excipients-suppliers">FDA Guidance to Compounders</a> was released in February 2026, advising compounders to ensure that their suppliers test ingredients and properly label them to certify quality and appropriate use.<br><strong>Link</strong>: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/optimal-balance-pharmacy-issues-voluntary-nationwide-recall-certain-lots-compounded-glutathione-200">FDA Press Release</a> and <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99662">FDA Enforcement Report </a></p>
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