A Houston compounding pharmacy is recalling one lot of injectable glutathione after testing found elevated levels of bacterial endotoxins, according to a report on the FDA notice. It is the second Texas pharmacy to issue a recall of injectable products over endotoxin concerns, weeks after an Austin compounding pharmacy announced a similar action.

The product involved is compounded glutathione 200 mg/mL in 30 mL multi-dose vials, distributed by Optimal Balance Pharmacy. Glutathione is described in the report as a naturally occurring antioxidant made by the liver, with compounded injectable versions used off-label in the wellness and cosmetics industry.

Why endotoxins matter

The FDA said injectable products with elevated bacterial endotoxin levels could cause serious and potentially life-threatening reactions. The agency listed fever, low blood pressure, inflammatory reactions, anaphylactic shock and death among the possible outcomes.

Pharmacy testing on the recalled products identified the elevated endotoxin levels that prompted the action. The recall covers a single lot rather than the pharmacy's full product range.

Reported adverse events

Optimal Balance Pharmacy has received reports of adverse events, according to the FDA. Those reports included fever, chills, severe headache, nausea, vomiting, pain, and symptoms consistent with an allergic reaction.

Where the product went

The recalled compounded glutathione was distributed to consumers in 14 states. Those states are Texas, Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Utah, Vermont and Washington.

The affected product carries product code LG342009076 and a use-by date of October 4, 2026. It was supplied as a multi-dose vial.

What the FDA says about the compound

The FDA has not reviewed or approved any version of injectable glutathione for safety and effectiveness, according to the report. The benefits of injectable glutathione are described as not well-defined.

The report says compounded glutathione injections are nonetheless widely used off-label for skin brightening and reduction of hyperpigmentation, as well as for cellular detoxification, immune support and countering oxidative stress.

What customers are told

Anyone holding products from the affected lot should stop using them immediately and quarantine them, according to the pharmacy. Customers are told to contact Optimal Balance Pharmacy to arrange retrieval and proper disposal.

Outlook

Anyone experiencing symptoms that may be related to the recalled product should contact a physician immediately, the pharmacy said. The report does not state how many vials were distributed or whether further lots are under review.