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 is compounded glutathione 200 mg/mL in 30 mL multi-dose vials, distributed by Optimal Balance Pharmacy. Glutathione is a naturally occurring antioxidant made by the liver, and the compounded injectable versions of it are used off-label by 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, listing fever, low blood pressure, inflammatory reactions, anaphylactic shock and death among the possible outcomes. That is not a theoretical hazard in an injectable: it is the reason sterile compounding is held to the standard it is.

The elevated levels turned up in the pharmacy's own testing, which is what triggered the action. The recall covers a single lot, not the pharmacy's full product range.

Reports already in hand

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.

Fourteen states

The recalled lot went to consumers in 14 states: Texas, Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Utah, Vermont and Washington. It carries product code LG342009076 and a use-by date of October 4, 2026, and was supplied as a multi-dose vial.

A product the agency never assessed

The FDA has not reviewed or approved any version of injectable glutathione for safety and effectiveness, and the benefits of injectable glutathione are described in the report as not well-defined. That gap has not slowed the market: the injections are widely used off-label for skin brightening and reduction of hyperpigmentation, as well as for cellular detoxification, immune support and countering oxidative stress.

What holders of the lot are told

Anyone holding products from the affected lot should stop using them immediately and quarantine them, according to the pharmacy, then contact Optimal Balance Pharmacy to arrange retrieval and proper disposal. Anyone experiencing symptoms that may be related to the recalled product should contact a physician immediately, the pharmacy said.

Bottom line

Two Texas compounders in a matter of weeks, same failure mode, same route of administration. The report does not state how many vials were distributed or whether further lots are under review, and those are the two numbers worth watching.