Recall Summary
| Recall number | D-0084-2027 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-10-28 |
| Company | Greenwich Rx |
| Units affected | 4,319 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
Greenwich Rx recall news matters to anyone who uses injectable glutathione products. On October 28, 2026, the U.S. Food and Drug Administration posted a recall of a glutathione injection made by Greenwich Rx. The agency cited microbial contamination of sterile products. It classified the action as Class I, its most serious level. About 4,319 units are affected. This guide explains what was recalled, why it matters, and what to do next.
What the Greenwich Rx Recall Covers
The Greenwich Rx recall covers one injectable product. The FDA record lists it as Glutathione Injection, 200 mg/mL. It comes in a 10 mL multi-dose vial. The label reads “Rx only” and “Subcutaneous Only.” That means it is meant for injection under the skin, not into a vein.
The listed ingredients are Glutathione-L, ascorbic acid, sodium hydroxide, and bacteriostatic water. Glutathione is an antioxidant that the body makes naturally. Injectable versions are often used in wellness and aesthetic settings. However, any injectable product must be sterile. A contamination problem with an injection is treated very seriously.
The agency record lists the scope as 4,319 units. It does not give a full sales history in the data provided here. For example, it does not say which states or clinics received the vials. Lot numbers and expiration dates are typically listed in the official notice. As a result, readers should check that notice directly before assuming a vial is safe.
Because the product is prescription only, most people received it through a prescriber, clinic, or pharmacy. In most cases, the provider who supplied it will have purchase records. Those records can help confirm whether your vial is part of the Greenwich Rx recall.
The Hazard and Reported Injuries
The FDA lists the hazard as “Microbial Contamination of Sterile Products.” In plain terms, the product may not be sterile. Bacteria, fungi, or other microbes could be present. A sterile injection should contain none of these.
Injecting a contaminated product can introduce germs directly into the body. Typically, this can cause infection at the injection site. Signs may include redness, swelling, warmth, pain, or pus. In more serious cases, infection can spread. People with weakened immune systems may face higher risk. Multi-dose vials add another concern, because each puncture is used again over time.
The FDA classified this as a Class I recall. Under FDA definitions, Class I means there is a reasonable probability that use could cause serious health problems or death. It is the highest risk tier the agency uses. However, the classification describes risk. It does not by itself confirm that anyone was harmed.
The agency record for this Greenwich Rx recall does not state whether injuries have been reported. We will not claim either way. If you have symptoms after using this product, talk to a doctor. The key facts from the agency record are below.
| Detail | Information |
|---|---|
| Recall number | D-0084-2027 |
| Issuing agency | U.S. Food and Drug Administration |
| Date | October 28, 2026 |
| Company | Greenwich Rx |
| Product | Glutathione Injection, 200 mg/mL, 10 mL multi-dose vial |
| Hazard | Microbial Contamination of Sterile Products |
| Units affected | 4,319 units |
| Severity | Class I |
What To Do If You Own This Product
First, stop using the product if you think it may be affected. Do not inject any more doses from the vial. Set it aside in a safe place, away from children. Do not throw it out yet. The vial and its packaging may help confirm details later.
Next, identify the product. Look for “Glutathione Injection” and “200 mg/mL” on the label. Check for “10 mL multi-dose vial” and “Greenwich Rx.” Then compare any lot number and expiration date to the official notice. For example, take a clear photo of the label before you do anything else. That photo creates a simple record.
For the remedy, follow the instructions in the official notice. You can find it at the FDA Enforcement Report for drug recalls. Search for recall number D-0084-2027. The notice is the controlling source for return, disposal, or refund steps. We are not stating the remedy here. The notice gives the correct directions for this Greenwich Rx recall.
Finally, contact the right people. Call the prescriber or clinic that supplied the product. If you feel unwell, see a doctor promptly. Tell them you used a recalled injection. You can also report side effects to FDA MedWatch. In most cases, these reports help the agency track safety problems.
Does a Greenwich Rx Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. The FDA and the company use it to remove a risky product from the market. A recall does not mean anyone has filed a claim. It also does not mean anyone has been found legally responsible.
We have not verified any lawsuit tied to this Greenwich Rx recall. Owning a recalled vial, by itself, is generally not enough to bring a claim. Typically, a product liability case needs more. You usually must show an injury. You must also show the product likely caused that injury.
For example, a person who developed an infection after an injection may have a different situation. Medical records, the vial, and the lot number could all matter. However, every case depends on its own facts. State laws and filing deadlines also vary. As a result, waiting too long can limit your options.
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If you believe you were harmed, speak with a licensed attorney. Many product liability lawyers offer free consultations. They can review your records and explain your choices. You may be eligible to pursue a claim, depending on your facts. No one can guarantee an outcome or compensation.
How Recalls Connect to Mass Tort Cases
A recall can become important evidence in later litigation. It shows that a safety problem was officially identified. Lawyers often study recall notices, agency records, and inspection reports. They look for when a company learned of a problem and what it did next. However, a recall does not prove that a specific injury was caused by the product.
History shows this pattern. In 2021, Philips recalled millions of CPAP and ventilator devices over degrading foam. Thousands of lawsuits followed and were grouped into federal multidistrict litigation. Takata airbags are another example. Defective inflators led to the largest auto recall in U.S. history. Litigation followed, and Takata pleaded guilty to a federal fraud charge in 2017.
Not every recall leads to a mass tort. In most cases, recalls end without major litigation. Mass torts usually form when many people report similar injuries. Whether that happens after the Greenwich Rx recall is unknown. Watching official sources is the best way to stay informed.
Frequently Asked Questions
What product is part of the Greenwich Rx recall?
The recall covers Glutathione Injection, 200 mg/mL, in a 10 mL multi-dose vial. It is labeled “Rx only” and “Subcutaneous Only.” The FDA lists 4,319 affected units.
Why is the Greenwich Rx recall classified as Class I?
The FDA cited microbial contamination of sterile products. Class I is the agency’s most serious recall level. It means there is a reasonable probability of serious health problems or death.
Have injuries been reported from the Greenwich Rx recall?
The agency record does not say whether injuries have been reported. If you used this product and feel unwell, contact a doctor. You can also report problems to FDA MedWatch.
How do I get a remedy for my vial?
Follow the instructions in the official FDA notice for recall number D-0084-2027. That notice is the correct source for return or disposal steps. Your prescriber or clinic may also be able to help.
Can I file a lawsuit because of the Greenwich Rx recall?
A recall alone is not a legal claim. If you were injured and the product likely caused it, you may be eligible to pursue one. A licensed attorney can review your situation.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed November 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.