Recall Summary
| Recall number | D-0865-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-16 |
| Company | American Regent, Inc. |
| Units affected | 31,935 |
| 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
American Regent recall news reached hospitals and pharmacies this month. On September 16, 2026, the U.S. Food and Drug Administration posted a Class I recall. The company is American Regent, Inc., based in Shirley, New York. The product is an injectable epinephrine drug in a 30 mL multiple-dose vial. The FDA record cites particulate matter and a lack of assurance of sterility. Class I is the agency’s most serious category. As a result, patients and providers should understand what this recall means.
What the American Regent Recall Covers
The recalled product is Epinephrine Injection, USP, 30 mg/30 mL (1 mg/mL). It comes in a 30 mL multiple-dose vial. The label says “Rx Only.” It is labeled for intravenous infusion, intramuscular use, and subcutaneous use. The National Drug Code (NDC) is 0517-3030-01. The labeler is American Regent, Inc., of Shirley, NY 11967.
The FDA recall number is D-0865-2026. The agency record lists 31,935 units in scope. However, the verified data summarized here does not list lot numbers or expiration dates. For lot-level details, check the official FDA enforcement report. In most cases, that notice holds the most complete product details.
This is not a consumer retail product. Typically, a multiple-dose epinephrine vial is used in hospitals, clinics, and surgical settings. It is different from the auto-injector pens many people carry for allergies. For example, a patient would not buy this vial at a local drugstore. Instead, a nurse or doctor draws the dose and gives it.
Epinephrine has many clinical uses. It can treat severe allergic reactions. It is also used in certain settings to support low blood pressure. Because it is often used in urgent care, supply matters to hospitals. The american regent recall means facilities must check their stock and act on the affected vials.
The Hazard and Reported Injuries
The FDA record cites two problems. The first is the presence of particulate matter. The second is a lack of assurance of sterility. The record says the particles were identified as nylon, cellulosic, acrylic, polyethylene, and glass. It also notes broken and leaking vials.
Why do particles matter in an injection? Injected drugs go straight into the body. Foreign material can cause harm once it gets there. For example, particles entering a vein may irritate the vessel wall. They can also travel through the bloodstream. Medical literature links injected particles to inflammation, clots, and small blockages. Glass fragments are a particular concern.
Sterility is the second issue. Injectable drugs must be sterile because they bypass the body’s natural defenses. A broken or leaking vial may allow microbes to enter. As a result, a patient could face a risk of infection. However, the actual risk to any one patient depends on many factors.
The FDA classified this as a Class I recall. That class is used when there is a reasonable probability that a product could cause serious health problems or death. It is a risk rating, not proof of harm. The agency record for the american regent recall does not state whether injuries have been reported. This guide makes no claim either way.
| Recall Number | D-0865-2026 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | September 16, 2026 |
| Company | American Regent, Inc. |
| Product | Epinephrine Injection, USP, 30 mg/30 mL (1 mg/mL), 30 mL Multiple-Dose Vial, NDC 0517-3030-01 |
| Units Affected | 31,935 units |
| Severity | Class I |
What To Do If You Own This Product
Most patients will never hold this vial themselves. Instead, it stays in a hospital or clinic pharmacy. If you received an epinephrine injection recently, you likely cannot tell which vial was used. Your care team or the facility pharmacy can help. Ask them whether the american regent recall affected your treatment.
Healthcare facilities should check inventory right away. Look for NDC 0517-3030-01 on the vial and carton. Stop using any affected product. Do not try to inspect vials by eye and keep using ones that look clean. The remedy instructions are not repeated here. Follow the instructions in the official FDA notice linked on this page.
If you have health concerns, talk to a doctor. Typically, signs of a problem after an injection might include redness, swelling, pain, or fever. Seek urgent care if symptoms are severe. You or your provider can also report a suspected reaction to FDA MedWatch. The MedWatch phone line is 1-800-FDA-1088.
Keep good records. For example, write down the date and place of any injection. Request copies of your medical records if you have concerns. Save any notices or letters from your provider. In most cases, these records matter if you later need answers about the american regent recall.
Does a American Regent Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. A company removes or corrects a product, and the FDA monitors the process. The american regent recall is a safety step taken to reduce risk. On its own, it does not create a legal claim for anyone.
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A legal claim usually needs more than a recall. Typically, a person must show an actual injury. They must also show that the product likely caused that injury. For example, medical records may need to link a specific vial to a specific harm. That link can be hard to prove with hospital-administered drugs.
As of this writing, we have not verified any lawsuit tied to the american regent recall. That could change over time. However, no one should assume a case exists or will exist. Filing deadlines, called statutes of limitations, vary by state. As a result, timing can matter if you believe you were hurt.
If you think this drug harmed you, consider speaking with a licensed attorney. Many product liability lawyers offer free consultations. They can review your records and explain your options. You may be eligible to pursue a claim, depending on your facts. No outcome or payment is guaranteed.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. A recall notice can show that a company identified a defect. It can also show when the problem was found. For example, Philips recalled millions of CPAP and ventilator devices in 2021 over degrading sound-abatement foam. Lawsuits followed and were consolidated in federal court in Pittsburgh. Philips later agreed to major settlements.
The Takata airbag recall is another example. Faulty inflators could rupture and send metal fragments into vehicles. Tens of millions of vehicles were recalled. Litigation followed, and Takata filed for bankruptcy in 2017. However, not every recall leads to a mass tort. Many recalls end without any litigation at all.
Drug recalls follow the same pattern. In 2018, valsartan blood pressure drugs were recalled over a possible cancer-causing impurity. Lawsuits were later grouped into federal multidistrict litigation in New Jersey. In most cases, courts look at injuries, causation, and company conduct. The recall itself is only one piece of that picture.
Frequently Asked Questions
What product is part of the American Regent recall?
The american regent recall covers Epinephrine Injection, USP, 30 mg/30 mL (1 mg/mL) in a 30 mL multiple-dose vial. The NDC is 0517-3030-01. The FDA record lists 31,935 units.
Why was this epinephrine recalled?
The FDA record cites particulate matter and a lack of assurance of sterility. Particles were identified as nylon, cellulosic, acrylic, polyethylene, and glass. The record also notes broken and leaking vials.
Does this recall affect my EpiPen or auto-injector?
This recall covers a 30 mL multiple-dose vial, not an auto-injector pen. That vial is typically used in hospitals and clinics. If you are unsure about any product, ask your pharmacist.
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 September 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.