COMPANY ANNOUNCEMENT
Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
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Recall Reason DescriptionElevated Endotoxin level
- Company Name:
- Optimal Balance Pharmacy
- Brand Name:
-
Brand Name(s)Optimal Balance Pharmacy
- Product Description:
-
Product DescriptionGlutathione Injection 200MG/ML (30ML), Multi-Dose Vial
Company Announcement
FOR IMMEDIATE RELEASE – August 19, 2026 – Houston, Texas, Optimal Balance Pharmacy is voluntarily recalling one lot of Compounded Glutathione 200 MG/ML 30 ML Multi-Dose Vials to the patient level. The product is being recalled because pharmacy testing identified elevated bacterial endotoxin levels.
Risk Statement: There is reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death. To date, Optimal Balance Pharmacy has received reports of adverse events including fever, chills, severe headache, nausea, vomiting, pain, and symptoms consistent with an allergic reaction.
Glutathione Injection is used to help fight cell damage, support the immune system, and clears out toxins in the liver. The affected product information is as follows:
Product Description | Package Color | Package Color | Package Color |
|---|---|---|---|
Glutathione Injection 200MG/ML | Multi-Dose Vial | LG342009076 | October 4, 2026 |
This compounded glutathione was distributed to consumers in Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont, Washington.
Optimal Balance Pharmacy is notifying its prescribers and patients by telephone and mail and is arranging for retrieval and proper disposition of the recalled product.
Patients who have product which is being recalled should:
- Stop using the product immediately and quarantine any product subject to this recall. Patients and prescribers will receive a full refund for recalled product if they have not already been reimbursed.
- Contact Optimal Balance Pharmacy to arrange for retrieval and proper disposition of the recalled product.
- Contact their prescribing physician if they have experienced any symptoms or problems that may be related to use of this product.
Prescribers and patients with questions regarding this recall can contact Optimal Balance Pharmacy at (218) 919-2964, 9am-5pm CST Monday through Friday.
Your assistance is appreciated and necessary to prevent consumer illness or patient harm.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- Optimal Balance Pharmacy
- (218) 919-2964
