Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & st
Summary
The FDA issued a Class I for Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutath by OPTIMAL BALANCE PHARMACY. Reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin..
Details
Source
Drug Recall
External ID
D-0851-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
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/Code Info: Lot#: LG342009076, Beyond Use Date: 10/4/26
Quantity Affected: 53 vials
Reason for Recall
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Distribution
USA Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-05
Company
Houston, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OPTIMAL BALANCE PHARMACY) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OPTIMAL BALANCE PHARMACY have FDA actions?
This is the only FDA action we have on record for OPTIMAL BALANCE PHARMACY in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0851-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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