FDA recall D-0772-2026

Product

Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

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

2026-07-01

Report date

2026-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0772-2026