FDA Drugs recall ·
Glutathione 200 mg/mL, 30 mL sterile multidose vial… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0851-2026
- Date
- (initiated August 5, 2026)
- Company / brand
- Optimal Balance Pharmacy
2204 Cypress Creek Pkwy, Houston, TX, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 53 vials
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: LG342009076, Beyond Use Date: 10/4/26
Distribution
USA Nationwide.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0851-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.