A compounding pharmacy has issued a nationwide recall of injectable glutathione after testing raised concerns that some of the medication could contain elevated levels of bacterial toxins capable of causing serious or potentially life-threatening reactions.
Greenwich Rx is recalling multiple lots of its compounded Glutathione Injection 200 mg/mL, according to an Oct. 1 notice from the U.S. Food and Drug Administration.
The medication was shipped directly to patients across the United States between June 26 and Sept. 21, 2026.
The recall involves 10 mL packages of injectable glutathione, an antioxidant that has been used in some wellness treatments and therapies marketed for purposes including liver support, anti-aging and skin health.
Why Is Greenwich Rx Glutathione Being Recalled?
The concern centers on elevated levels of endotoxins.
Endotoxins are toxic substances associated with certain bacteria. When excessive amounts enter the body through an injectable medication, the consequences can be much more serious than those associated with ordinary contamination of a topical or oral product.
According to the FDA recall notice, exposure to elevated endotoxin levels through injection can potentially cause fever, low blood pressure, inflammatory reactions and anaphylactic shock. In severe cases, exposure can be fatal.
Greenwich Rx had received two reports of adverse reactions requiring emergency department treatment as of the Oct. 1 recall announcement.
The company attributed those incidents to improper administration of the medication.
Which Greenwich Rx Products Are Affected?
The recall applies specifically to Greenwich Rx Glutathione Injection 200 mg/mL in 10 mL packages.
Affected lot numbers and their corresponding beyond-use dates are:
| Lot Number | Beyond-Use Date |
|---|---|
| 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 |
Patients who received compounded glutathione from Greenwich Rx during the affected distribution period should check the lot number on their medication against the recall list.
What Should Patients Do With Recalled Glutathione?
Consumers who have one of the recalled products should stop using it and discard it, according to the recall instructions.
Greenwich Rx is contacting customers and distributors by email and coordinating disposal of affected medication.
Patients who believe they experienced an adverse reaction should contact a health care provider. Serious reactions or product-quality problems can also be reported through the FDA’s MedWatch Adverse Event Reporting Program.
Consumers with questions about the recall can contact Greenwich Rx at 866-552-4916 or GreenwichRx7542@sedgwick.com.
What Is Injectable Glutathione?
Glutathione is an antioxidant naturally produced by the body and involved in several biological processes, including helping protect cells from oxidative damage.
Compounded injectable versions have also become part of the expanding wellness market, where glutathione may be promoted for purposes such as liver support, skin appearance or anti-aging treatments.
The Greenwich Rx recall does not mean that all compounded glutathione products are affected. The recall applies to the specific Greenwich Rx product and lots identified by the company and FDA.
What Are Compounding Pharmacies?
Compounding pharmacies produce customized medications rather than simply dispensing commercially manufactured drugs.
A pharmacist might compound a medication when a patient requires a dosage or formulation that is not commercially available. For example, a patient might need a medication without a particular dye or other ingredient, or a child or animal might require a liquid formulation at a different concentration.
Compounding can also play a role during drug shortages when commercially manufactured supplies cannot meet demand.
The practice gained significantly more public attention during shortages of popular GLP-1 weight-loss and diabetes medications. Compounding pharmacies produced versions of medications containing semaglutide and tirzepatide while shortages affected access to FDA-approved products.
Compounded Drugs Are Different From FDA-Approved Drugs
There is an important distinction between an FDA-approved medication and a compounded version of a drug.
Compounded medications are not individually reviewed and approved by the FDA in the same manner as commercially manufactured prescription drugs. That means the agency does not evaluate each compounded formulation for safety, effectiveness and quality before it reaches patients.
Compounding pharmacies are still subject to federal and state requirements depending on how they operate, but the regulatory framework differs from the approval and manufacturing process governing conventional pharmaceutical products.
Sterile injectable medications can present particular concerns because contamination introduced during preparation can be delivered directly into the body.
Previous contamination incidents involving compounded injectable medications have resulted in serious illnesses and have increased scrutiny of sterile compounding practices.
GLP-1 Boom Has Put Compounding Pharmacies in the Spotlight
The explosive popularity of weight-loss drugs has brought the compounding industry into much greater public view.
During shortages of FDA-approved semaglutide and tirzepatide products, compounded alternatives became widely available, including through online and telehealth providers.
As supplies of commercially manufactured GLP-1 medications improved and drugs were removed from the FDA shortage list, questions emerged over when pharmacies could legally continue producing compounded copies.
The issue has also triggered disputes between pharmaceutical manufacturers and companies selling compounded alternatives.
For consumers, the Greenwich Rx recall highlights a broader consideration when obtaining injectable medications from a compounding pharmacy: knowing where the medication was produced, whether the pharmacy follows appropriate sterile-compounding standards and what regulatory oversight applies to the facility.
Patients considering compounded medications should discuss the risks and benefits with a qualified health care professional and verify the credentials of the pharmacy dispensing the medication.