FDA-Drug2026-09-09Class ICHEMICAL
Optimal Balance Pharmacy Glutathione 200 mg/mL injection recalled for bacterial endotoxin contamination
What this means
Optimal Balance Pharmacy's Glutathione 200 mg/mL injectable solution failed quality testing and was found to contain bacterial endotoxin levels above safe limits. This contamination poses a risk of serious infection or systemic reaction when injected. The affected lot (LG342009076) was distributed nationwide.
- If you have received vials from lot LG342009076 with beyond-use date 10/4/26, do not use them.
- Contact Optimal Balance Pharmacy or your healthcare provider for guidance on replacement or disposal.
- If you received an injection from this lot, contact your doctor immediately to report and discuss any symptoms.
The agency's original wording
Hazard
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide.
Affected count
53 vials
Manufactured in
2204 Cypress Creek Pkwy, N/A, Houston, TX, United States
Products
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0851-2026More Optimal Balance Pharmacy recalls
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