Recall - VMC (Compounded Glutathione 200 mg/mL Multi-Dose Vials) produced by Victory Medical Center Pharmacy - Elevated Endotoxin level

Summary

Company Announcement

FOR IMMEDIATE RELEASE - August 5, 2026 - Austin, Texas, Victory Medical Center Pharmacy is voluntarily recalling certain lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels

Risk Statement: There is reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death. To date, Victory Medical Center Pharmacy 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.

The affected product information is as follows:

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

Victory Medical Center Pharmacy is notifying its prescribers and patients by telephone and mail and is arranging for retrieval and proper disposition of the recalled product.

Patients who have product from an affected lot should:

• Stop using the product immediately and quarantine any product subject to this recall. Patients and prescribers will receive a full refund for recalled product if they have not already been reimbursed.
• Contact Victory Medical Center Pharmacy to arrange for retrieval and proper disposition of the recalled product.
• Contact their prescribing physician if they have experienced any symptoms or problems that may be related to use of this product.

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

Your assistance is appreciated and necessary to prevent consumer illness or patient harm.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178