FDA Announces Nationwide Recall of Compounded Glutathione by Greenwich Rx Due to Elevated Endotoxin Levels

What this means for your practice

This nationwide recall of a compounded injectable product underscores critical compliance considerations for healthcare businesses, particularly those operating medspas, wellness clinics, or offering telehealth services that involve compounded medications. The risk associated with elevated endotoxin levels in injectables highlights the severe patient safety implications, ranging from inflammatory reactions to anaphylactic shock and death. For practices, this event emphasizes the paramount importance of robust due diligence in selecting compounding pharmacies and meticulously verifying the safety and quality of all administered products. Furthermore, the FDA's notice explicitly mentions instances where a glutathione product *not formulated for IV use* led to emergency department visits when administered intravenously. This distinction is crucial for practices, especially medspas, that commonly offer IV infusion therapies. It reinforces the necessity for strict adherence to a product's intended route of administration as specified by the compounding pharmacy and ensuring that staff are thoroughly trained on these protocols. Regular monitoring of FDA recall alerts and maintaining a rigorous inventory management system to identify and quarantine affected lots are essential to mitigate risks, ensure patient safety, and avoid significant regulatory scrutiny.

Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, has initiated a voluntary nationwide recall of specific lots of its compounded Glutathione Injection (200 mg/mL) due to the potential for elevated endotoxin levels. This action is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA) and aims to protect patient safety from potentially severe health consequences.

Understanding the Recall

The recall targets compounded glutathione products dispensed in 10mL multidose vials, which were specifically intended for subcutaneous injection. The decision to recall was prompted by the risk of elevated endotoxin levels, a critical concern for any injectable medication. Endotoxins are lipopolysaccharides found in the outer membrane of gram-negative bacteria, and even in small amounts, they can trigger significant immune responses in humans when introduced into the bloodstream.

Products Affected

The voluntary recall impacts the following specific lots of compounded glutathione 200 mg/mL, distributed to patients nationwide between June 26, 2026, and September 21, 2026:

• Glutathione Injection 200 mg/mL (10mL)

Customers who received glutathione from one of these recalled lots are being notified by mail by Greenwich Rx.

The Gravity of Elevated Endotoxin Levels

The risk statement issued by Greenwich Rx and acknowledged by the FDA highlights the severe dangers associated with injectable products containing elevated endotoxin levels. There is a reasonable probability that these products could lead to significant medical events, including:

• Fevers
• Hypotension (low blood pressure)
• Inflammatory reactions
• Anaphylactic shock
• Death

The company has, to date, received two reports involving patients who sought emergency department care. These instances followed the intravenous (IV) administration of a glutathione product that, importantly, was *not formulated for IV use*. This detail underscores the critical importance of adhering strictly to the intended route of administration for compounded products.

Actions for Healthcare Providers and Patients

For customers (including healthcare providers and patients) who have received the recalled compounded glutathione product:

1. Stop Use Immediately: Discontinue using any product from the affected lot numbers.
2. Disposal: Follow the disposal instructions provided in the recall notification received from Greenwich Rx.
3. Patient Health: Patients who believe they have experienced a health issue potentially related to the product should contact their healthcare provider without delay. Healthcare providers should assess any patients who may have received the affected product for adverse reactions.

Reporting Adverse Events:

Adverse reactions or quality problems experienced with the use of this product can also be reported directly to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online at www.fda.gov/medwatch/report.htm, by regular mail, or by fax. A reporting form can be downloaded from www.fda.gov/MedWatch/getforms.htm or requested by calling 1-800-332-1088.

Contact for Questions:

For any questions regarding this recall, customers may contact Sedgwick at (866) 552-4916 or [email protected]. The contact center operates Monday through Friday, 8:00 AM to 5:00 PM Eastern Time.

Regulatory Implications for Healthcare Businesses

This recall serves as a critical reminder for all healthcare businesses, especially those utilizing compounded medications or offering injectable therapies. Maintaining rigorous oversight of pharmaceutical sourcing, understanding the specific formulations and intended routes of administration for all compounded products, and establishing robust internal protocols for medication storage and administration are non-negotiable aspects of patient safety and regulatory compliance. Practices should regularly consult FDA safety alerts and recalls to ensure all products in their inventory are safe and authorized for use.

Key Facts

Frequently Asked Questions

What product is being recalled by Greenwich Rx?

Greenwich Rx is recalling specific lots of its compounded Glutathione Injection 200 mg/mL, dispensed in 10mL multidose vials.

Why is this product being recalled?

The product is being recalled due to potential elevated endotoxin levels.

What are the potential health risks associated with elevated endotoxin levels in an injectable product?

Injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock, and death.

What should patients or healthcare providers do if they have the recalled product?

Customers who received glutathione from one of the recalled lots should stop using the product and follow the disposal instructions provided in the recall notification. Patients who believe they have experienced a health issue related to the product should contact their healthcare provider.

Was the recalled glutathione product intended for intravenous (IV) use?

No, the recalled glutathione product was intended for subcutaneous injection. The recall notice mentions two reports involving patients who received emergency department care following intravenous (IV) administration of a glutathione product that was not formulated for IV use.

Source: FDA — Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels · Thu, 01 Oct 2026 00:00:00 EDT