10/18/2026 | Press release | Distributed by Public on 10/18/2026 10:46
On October 1, 2026, Greenwich Rx, a 503A compounding pharmacy, voluntarily recalled specific lots of its compounded glutathione. The product is being recalled due to potential elevated levels of bacterial toxins.
There is reasonable probability that injectable products with elevated levels of bacterial toxins could cause significant medical events including fevers, low blood pressure, inflammation, anaphylactic shock and death.
To date, Greenwich Rx has received two reports involving patients who received emergency department care following intravenous administration of a glutathione product that was not formulated for intravenous use.
Glutathione is a naturally occurring antioxidant that helps protect cells from stress. The voluntary recall affects the following lots of compounded glutathione 200 mg/mL dispensed in 10 mL multidose vials and intended for subcutaneous injection:
| Product Description | Strength | Package Size | Lot Number | Beyond Use Date |
|
Glutathione Injection |
200 mg/mL | 10 mL | 0060-062426-1 | 10/02/2026 |
| 0060-062726-1 | 10/05/2026 | |||
| 0060-070926-1 | 10/17/2026 | |||
| 0060-071426-1 | 10/22/2026 | |||
| 0060-071426-2 | 10/22/2026 | |||
| 0060-072026-1 | 10/28/2026 | |||
| 0060-072726-1 | 11/04/2026 | |||
| 0060-072926-1 | 11/06/2026 | |||
| 0060-073126-1 | 11/08/2026 | |||
| 0060-080426-1 | 11/12/2026 |
The glutathione was distributed to patients nationwide between June 26, 2026, and September 21, 2026.
Greenwich Rx is notifying patients of this voluntary recall by mail. 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 that may be related to the product should contact their healthcare provider.
Patients can direct questions regarding this recall to Sedgwick at (866) 552-4916 or [email protected] Monday through Friday between 8:00 AM to 5:00 PM Eastern Time.
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.
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