Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels

FDA recall notice · announced August 19, 2026 · Optimal Balance Pharmacy

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Reason for recall

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Notes

Distribution: USA Nationwide.
Lot/code information: Lot#: LG342009076, Beyond Use Date: 10/4/26
Quantity: 53 vials
Status: Ongoing
Products in this recall event:
- 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 Bal (D-0851-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.