FDAClass IRecall started August 5, 2026

Glutathione 200 mg/mL Recall: Endotoxin

Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For…

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Glutathione 200 mg/mL recalled?

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full 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

Which lot codes, UPCs or models are affected?

Lot#: LG342009076, Beyond Use Date: 10/4/26

Agency record number
D-0851-2026
Product
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For…
Recalling firm
OPTIMAL BALANCE PHARMACY
Quantity
53 vials
Distribution
USA Nationwide.
Recall started
August 5, 2026
Report date
September 9, 2026
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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