FDA Drug recall D-0851-2026
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for inj…
- FDA Drug
- Class I
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class I recall of Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for inj… by Optimal Balance Pharmacy, citing microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0851-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-05 |
| Published | 2026-09-09 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Optimal Balance Pharmacy |
| Distribution | US |
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
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Identifiers
| code_info | Lot#: LG342009076, Beyond Use Date: 10/4/26 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0851-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.