FDAFDA recall D-0851-2026 · Sep 9, 2026
OPTIMAL BALANCE PHARMACY: Glutathione 200 mg/mL recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot#: LG342009076, Beyond Use Date: 10/4/26
- Quantity
- 53 vials
- Distribution
- USA Nationwide.
- Recalling firm
- OPTIMAL BALANCE PHARMACY, Houston, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-05
Source: openFDA enforcement record D-0851-2026 · search recall number D-0851-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.