Nationwide Recall Issued for Glutathione Injections Over Dangerous Endotoxin Contamination

Optimal Balance Pharmacy is recalling a lot of compounded glutathione injections after testing found elevated bacterial endotoxin levels. Here is what patients should know.

A Houston-based compounding pharmacy has issued a nationwide recall of a compounded glutathione injection after testing identified elevated levels of bacterial endotoxins in one lot of the product.

The recall affects Glutathione Injection 200 mg/mL, supplied in 30 mL multi-dose vials, manufactured by Optimal Balance Pharmacy. According to the U.S. Food and Drug Administration (FDA), the pharmacy announced the voluntary recall on Aug. 19, 2026, and the agency published the safety alert on Aug. 20.

The affected product was distributed to patients in 14 states, making the recall relevant to consumers, prescribers, and health care providers across a large portion of the United States.

Which Glutathione Product Is Recalled?

The FDA identifies the recalled product as Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial.

Consumers should check their packaging carefully for the following information:

• Product: Glutathione Injection 200 mg/mL
• Container: 30 mL multi-dose vial
• Lot number: LG342009076
• Expiration date: Oct. 4, 2026
• Manufacturer: Optimal Balance Pharmacy

The FDA lists the recall reason as an elevated endotoxin level.

The product was distributed in Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont, and Washington.

Because this is a patient-level recall, people who may have received the affected product should not assume that the recall applies only to pharmacies or medical facilities. Patients who possess the recalled lot are specifically advised to stop using it.

Why Are Endotoxins a Concern?

Endotoxins are components associated with the outer membranes of certain bacteria. Even when bacteria themselves are no longer present, endotoxins can remain and trigger significant inflammatory responses when introduced into the body.

This is particularly important for injectable medications because the product is administered directly into the body rather than being exposed to the digestive system.

The FDA says injectable products containing elevated endotoxin levels could potentially cause serious medical events, including fever, low blood pressure, inflammatory reactions, anaphylactic shock, and death.

The concern is not simply that the medication may have been contaminated with ordinary bacteria. Rather, the presence of excessive endotoxin can itself pose a health risk.

Patients Have Reported Adverse Events

Optimal Balance Pharmacy said it has received reports of adverse events associated with the recalled product.

Reported symptoms include fever, chills, severe headache, nausea, vomiting, pain, and symptoms consistent with an allergic reaction, according to the FDA's published recall notice.

Patients who have used the recalled medication and subsequently developed concerning symptoms should contact their prescribing physician or another appropriate health care professional.

Anyone experiencing a severe or rapidly worsening reaction should seek urgent medical attention rather than waiting for a pharmacy response.

What Should Patients Do Now?

The FDA and Optimal Balance Pharmacy recommend several steps for people who have the recalled product.

First, stop using the affected product immediately. Patients should check the lot number on their vial rather than relying only on the product name.

Second, the recalled vial should be kept separate and should not be used while arrangements are made for its return and proper disposal. The pharmacy says it is contacting prescribers and patients by telephone and mail to coordinate retrieval.

Patients and prescribers who purchased the recalled product are eligible for a full refund if they have not already received reimbursement.

Anyone who believes they experienced a medical problem after using the injection should also inform their prescribing physician.

How Can Patients Report a Reaction?

The FDA says adverse reactions or quality problems associated with the recalled product can be reported through its MedWatch safety reporting program.

MedWatch allows patients and health care professionals to report suspected problems involving medical products. Reports can be submitted online, by mail, or by fax.

Questions specifically related to the Optimal Balance Pharmacy recall can be directed to the pharmacy at (218) 919-2964. The FDA notice lists the phone line as available Monday through Friday from 9 a.m. to 5 p.m. Central Time.

Why Compounded Injectable Drugs Require Special Attention

Compounded medications can play an important role when patients need formulations that are not readily available as commercially manufactured drugs. However, injectable compounded products must meet important quality and safety expectations because contamination can have serious consequences.

The FDA has previously issued safety alerts and recalls involving compounded sterile products when concerns about contamination or sterility arose.

The current recall also illustrates why patients should keep track of medication names, lot numbers, expiration dates, and prescribing information. These details can become critical when a safety alert is issued.

It is also important to distinguish the current recall from a general statement that all glutathione products are unsafe. The FDA's notice specifically identifies one lot of Optimal Balance Pharmacy's compounded glutathione injection.

What Is Glutathione?

Glutathione is a naturally occurring antioxidant involved in several processes in the body. Injectable glutathione has been promoted for a variety of purposes, including claims related to cellular health and detoxification.

However, the safety and effectiveness of compounded injectable glutathione can depend on the specific formulation, route of administration, manufacturing practices, and clinical circumstances.

An FDA Pharmacy Compounding Advisory Committee document has noted safety concerns associated with glutathione, particularly with injection and inhalation formulations, and has also stated that evidence for effectiveness for some proposed uses is limited or insufficient.

For that reason, patients should discuss the risks and expected benefits of glutathione injections with a qualified health care professional rather than relying solely on promotional claims.

A Reminder for Consumers

The current recall does not mean that everyone who has received glutathione injections will become ill. It does mean that people who have the specifically identified lot should take the recall seriously and follow the instructions provided by the pharmacy and FDA.

Consumers should check their vial for lot LG342009076 and the Oct. 4, 2026, expiration date. If the information matches, the product should not be used.

Patients who are uncertain whether their medication is included in the recall should contact their pharmacy, prescriber, or Optimal Balance Pharmacy for clarification.

Sources

U.S. Food and Drug Administration, “Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels.”

Disclaimer

This article is intended for general informational purposes only and is not medical advice. Patients should not make decisions about stopping, restarting, or changing prescribed treatments based solely on this article. Anyone who may have received the recalled product should follow the FDA and pharmacy recall instructions and consult a qualified health care professional about individual medical concerns.