Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Glutathione 200 mg/mL
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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
Drug: Alcohol
- Recalling firm
- Optimal Balance Pharmacy
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Aug 19, 2026 · FDA notice with lot numbers
- FDA recall number
- D-0851-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Alcohol recalls
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Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
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Class II · Moderate risk
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CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Class I · High risk
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Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I · High risk
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