FDA · Class I · September 9, 2026

Optimal Balance Pharmacy recall: Glutathione 200 mg/mL

Optimal Balance Pharmacy is recalling Glutathione 200 mg/mL because of microbial contamination – 53 vials. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 5, 2026. Distributed nationwide.

Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.

A pharmacy dispensing machine
Illustration: A pharmacy dispensing machine – not the recalled product. Photo: U.S. Air Force / Airman Trevor Calvert, public domain.
ProductGlutathione 200 mg/mL
BrandOptimal Balance Pharmacy
TypeDrugs
ClassificationClass I
Recall dateAugust 5, 2026
Published by FDASeptember 9, 2026
Quantity53 vials
Recall ID99662
As listed by FDA

Recalled 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
    FDA recall number
    D-0851-2026
    Codes, lots and dates
    Lot#: LG342009076, Beyond Use Date: 10/4/26
    Quantity
    53 vials
    Classification
    Class I
Exactly as the agency lists them

Identifiers and details

FDA event ID
99662
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Houston, TX, United States

Why it was recalled

The problem: microbial contamination.

The reason the FDA lists: “Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.”

Where it was sold

Nationwide. Distribution as the FDA records it: “USA Nationwide.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99662, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is Optimal Balance Pharmacy Glutathione 200 mg/mL recalled?

Yes. Optimal Balance Pharmacy recalled it on August 5, 2026; FDA published it September 9, 2026 (Class I). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Because of microbial contamination. The reason given: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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