CLASS I ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Glutathione 200 mg/mL sterile multidose vial recalled
Optimal Balance Pharmacy is recalling Glutathione 200 mg/mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic, distributed nationwide in the US. The recall was initiated on 5 Aug 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0851-2026
- FDA event ID
- 99662
- Recalling firm
- Optimal Balance Pharmacy, Houston, TX
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 5 Aug 2026
- FDA classified
- 16 Sep 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Aug 2026 | Recall initiated by company | |
| 9 Sep 2026 | Published in enforcement report | +35 days |
| 16 Sep 2026 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide.
Questions about this recall
Why was it recalled?
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Which lots are affected?
Lot#: LG342009076, Beyond Use Date: 10/4/26
Where was it sold?
USA Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Glutathione recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glutathione Magnesium for Injection, all strengths recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Glutathione 200mg/ml, a)-vial, b)-vial, Refrigerate recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Glutathione 200mg/mL Preservative Free, Injectable-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Glutathione 200mg/ML Mdv recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Glutathione Injection,Glutathione 200MG/ML Injectable recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |