Why it was recalled
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: LG342009076, Beyond Use Date: 10/4/26
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0851-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 5, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 53 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- OPTIMAL BALANCE PHARMACY
Original FDA data
Every field from FDA enforcement report D-0851-2026, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 99662
- Address
- 2204 Cypress Creek Pkwy
- Code information
- Lot#: LG342009076, Beyond Use Date: 10/4/26
- Postal code
- 77090-3113
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0851-2026
- Classification
- Class I
- Recalling firm
- OPTIMAL BALANCE PHARMACY
- Product quantity
- 53 vials
- Reason for recall
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Aug 5, 2026
- Initial firm notification
- Center classification date
- Sep 16, 2026