Glutathione 200 mg/mL recall
FDA recall D-0851-2026 · initiated Aug 5, 2026
OPTIMAL BALANCE PHARMACY recalled Glutathione 200 mg/mL in Aug 2026 — an FDA Class I recall (D-0851-2026) because Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 53 vials
Details
- 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
- Recalling company
- OPTIMAL BALANCE PHARMACY
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide.
- Initiated
- Aug 5, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Glutathione 200 mg/mL recalled?
- OPTIMAL BALANCE PHARMACY recalled Glutathione 200 mg/mL in Aug 2026 — an FDA Class I recall (D-0851-2026) because Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Glutathione 200 mg/mL recalled?
- Per the FDA enforcement record, the reason for recall D-0851-2026 was: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Is a recalled Glutathione 200 mg/mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Glutathione 200 mg/mL are affected?
- Distributed: USA Nationwide.. The recall covers these lots — Lot#: LG342009076, Beyond Use Date: 10/4/26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0851-2026.