FDA recall D-0851-2026

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.

Distribution

USA Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-08-05

Report date

2026-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0851-2026