Class IDrug
Glutathione 200 mg/mL recall
Summary
OPTIMAL BALANCE PHARMACY is recalling Glutathione 200 mg/mL (drug). According to the FDA report, the reason is: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
Optimal Balance Pharmacy is recalling Glutathione 200 mg/mL 30 mL multidose vials because testing for bacterial endotoxin came back out of specification.
Why it matters
Products meant to be sterile, like injections, can carry bacteria or bacterial toxins (endotoxins) into the body if sterility isn't assured. That can cause fever, infection or more serious reactions, especially in people who are already ill or have weakened immune systems. Glutathione injections like this are compounded products, not FDA-approved drugs.
Who should pay attention
Clinics and patients who received glutathione injections from this pharmacy.
Distribution in the FDA report: USA Nationwide.
How to check your product
Check the lot number and beyond-use date on the vial.
Codes listed by the FDA: Lot#: LG342009076, Beyond Use Date: 10/4/26
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- 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.
- Lot / code info
- Lot#: LG342009076, Beyond Use Date: 10/4/26
- Quantity
- 53 vials
- Distribution
- USA Nationwide.
- Recalling company
- OPTIMAL BALANCE PHARMACY, Houston, TX United States
- Recall started
- August 5, 2026
- FDA report date
- September 9, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0851-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (OPTIMAL BALANCE PHARMACY) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.