Optimal Balance Pharmacy drug recall: Glutathione 200 mg/mL
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99662
- Recall initiated
- Aug 5, 2026
- Classified by FDA
- Sep 16, 2026
- Posted in Enforcement Report
- Sep 9, 2026
- Recalling firm
- OPTIMAL BALANCE PHARMACY
- Firm location
- Houston, TX, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 5, 2026. FDA classified it 42 days later, on Sep 16, 2026. Distribution reported by FDA: USA Nationwide.
Recalled products (1)
D-0851-2026 Class I Ongoing
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
Codes / lots: Lot#: LG342009076, Beyond Use Date: 10/4/26
Quantity: 53 vials
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 99662
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.