Glutathione 200 mg/mL — Class I drug recall D-0851-2026
Ongoing recall by OPTIMAL BALANCE PHARMACY, reported 2026-09-09, distributed nationwide. Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endoto
| Recall number | D-0851-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OPTIMAL BALANCE PHARMACY, Houston, TX, United States |
| Recall initiated | 2026-08-05 |
| Classified | 2026-09-16 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 53 vials |
| Reason classes | microbial contamination, sterility, specification failure |
| Lot numbers | LG342009076 |
| Expiration dates | 2026-10-04 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0851-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.