FDA Issues Nationwide Recall for Compounded Glutathione Due to Elevated Endotoxin Levels

What this means for your practice

This recall underscores the critical importance of robust quality control and supplier vetting for healthcare businesses that utilize compounded medications, particularly injectables. For telehealth brands, medspas, dental practices, and chiropractic offices, ensuring that any compounded products prescribed or administered originate from reputable pharmacies with stringent sterility and endotoxin testing protocols is paramount. Practitioners must maintain clear lines of communication with their compounding pharmacies and have immediate protocols in place for handling recalls, including patient notification and product retrieval. Furthermore, the reported adverse events highlight the necessity for providers to educate patients on potential side effects and the process for reporting any adverse reactions promptly, both to the prescribing physician and the FDA's MedWatch program. Compliance with recall directives is not merely a logistical exercise but a fundamental aspect of patient safety and regulatory adherence.

Washington D.C. – The U.S. Food and Drug Administration (FDA) has announced a voluntary nationwide recall initiated by Victory Medical Center Pharmacy for certain lots of its Compounded Glutathione 200 mg/mL Multi-Dose Vials. The recall, prompted by pharmacy testing that identified elevated bacterial endotoxin levels, emphasizes the critical need for vigilance in the compounding pharmacy sector and among healthcare providers utilizing these products.

The Recall Details

Victory Medical Center Pharmacy, based in Austin, Texas, is proactively recalling the affected compounded glutathione product to the patient level. The recall was announced on August 5, 2026, following the discovery of elevated bacterial endotoxin levels during internal pharmacy testing. Endotoxins are components of the outer membrane of gram-negative bacteria, and their presence in injectable medications, even if the bacteria themselves are not viable, can provoke severe systemic reactions in patients.

Potential Risks to Patients

The presence of elevated endotoxin levels in injectable products carries a reasonable probability of causing significant medical events. The FDA's risk statement indicates that such contamination could lead to serious adverse reactions, including fevers, hypotension (low blood pressure), inflammatory reactions, and potentially life-threatening conditions such as anaphylactic shock and death.

Victory Medical Center Pharmacy has already received reports of adverse events linked to the use of the recalled product. These reported symptoms include fever, chills, severe headache, nausea, vomiting, tachycardia (rapid heart rate), changes in blood pressure, body aches, and localized injection site reactions. These reports underscore the immediate danger posed by the affected vials to patient health and safety.

Affected Product Information

The recall specifically applies to certain lots of VMC Compounded Glutathione 200 mg/mL Multi-Dose Vials. The affected lot numbers and their corresponding expiration dates are:

• Lot Number: 1980571
• Lot Number: 1981940
• Lot Number: 1984345

This compounded glutathione product was distributed to consumers in three states: Texas, Florida, and New York. Providers and patients in these states who may have received this product should immediately verify their inventory against the listed lot numbers.

Actions for Patients and Prescribers

Victory Medical Center Pharmacy is actively notifying its prescribers and patients through telephone and mail to facilitate the retrieval and proper disposition of the recalled product. Both patients and prescribers are eligible for a full refund for any recalled product that has not already been reimbursed.

Patients who possess product from an affected lot are advised to take the following immediate steps:

1. Stop using the product immediately. 2. Quarantine any product subject to this recall. 3. Contact Victory Medical Center Pharmacy to arrange for the retrieval and proper disposition of the recalled product. 4. Contact their prescribing physician if they have experienced any symptoms or health problems that may be related to the use of this product.

Prescribers and patients with questions regarding this recall can contact Victory Medical Center Pharmacy directly at (512) 279-0985. The pharmacy's contact hours are Monday through Friday from 8:00 a.m. to 7:00 p.m. CST, Saturday from 9:00 a.m. to 5:00 p.m. CST, and Sunday from 12:00 p.m. to 5:00 p.m. CST.

Reporting Adverse Events

The FDA encourages healthcare professionals and patients to report any adverse reactions or quality problems experienced with the use of this product to the agency's MedWatch Adverse Event Reporting program. Reports can be submitted online at www.fda.gov/medwatch/report.htm, by regular mail, or by fax. Forms can be downloaded from www.fda.gov/MedWatch/getforms.htm or requested by calling 1-800-332-1088. This reporting is crucial for ongoing public health surveillance and intervention.

This recall serves as a critical reminder of the stringent quality control necessary for compounded medications and the robust communication channels required to ensure patient safety in the event of product anomalies. Healthcare providers are urged to review their sourcing and dispensing protocols for compounded products.

Key Facts

| Detail | Value | |---|---| | Company | Victory Medical Center Pharmacy | | Product | Compounded Glutathione 200 mg/mL Multi-Dose Vials | | Recall Reason | Elevated bacterial endotoxin levels | | Risk Statement | Reasonable probability of significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock, and death. | | Affected Lots | 1980571, 1981940, 1984345 | | Distribution | Texas, Florida, and New York |

Frequently Asked Questions

What specific product is being recalled?

Victory Medical Center Pharmacy is recalling certain lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials, branded as VMC.

Why is this product being recalled?

The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels, which pose a significant health risk.

What are the potential health risks associated with using the recalled product?

Injectable products with elevated endotoxin levels could cause serious medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock, and death. Reported adverse events include fever, chills, severe headache, nausea, vomiting, tachycardia, changes in blood pressure, body aches, and injection site reactions.

What should patients do if they have the recalled product?

Patients should immediately stop using the product, quarantine it, contact Victory Medical Center Pharmacy to arrange for retrieval and disposition, and contact their prescribing physician if they have experienced any symptoms or problems related to its use. They are also eligible for a full refund.

Which states received the recalled compounded glutathione?

The compounded glutathione was distributed to consumers in Texas, Florida, and New York.

Source: FDA — Victory Medical Center Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels · Wed, 05 Aug 2026 00:00:00 EDT