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Class IOngoing

OPTIMAL BALANCE PHARMACY recalls Glutathione 200 mg/mL

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
OPTIMAL BALANCE PHARMACY
Reason
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
USA Nationwide.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99662…

Products

  1. 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: 10/4/26Quantity: 53 vialsRecall no. D-0851-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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