Optimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
Optimal Balance Pharmacy is recalling 53 vials of Glutathione 200 mg/mL due to bacterial endotoxin contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Optimal Balance Pharmacy is recalling 53 vials of Glutathione 200 mg/mL, 30 mL sterile multidose vials. The product is a prescription-only medication intended for intramuscular or intravenous injection. The recall was initiated because out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product.
The affected product is identified by Lot Number LG342009076 and has a Beyond Use Date of 10/4/26. The recall covers distribution across the USA nationwide.
Consumers and healthcare providers should stop using the affected vials immediately. Patients should contact their healthcare provider for guidance on alternative treatments or further medical evaluation if they have already used the product.
The recalled product
- 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
- Manufacturer
- OPTIMAL BALANCE PHARMACY
- Affected units
- 53
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: LG342009076
- Beyond Use Date: 10/4/26
Distribution
Distributed nationwide across the United States.
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