---
title: Epinephrine Injection Recalled Nationwide Over Contamination Concerns
description: American Regent is recalling three lots of its multi-dose epinephrine vials over cracked containers and particulate matter. Auto-injectors are not affected.
author: Darie Nani (Editor-in-Chief)
updated: 2026-09-04T13:20:43.099Z
canonical: https://richhealthmagazine.com/article/american-regent-epinephrine-injection-recall
categories: Health
content_type: News
region: United States
publication: Rich Health Magazine
schema_type: Article
---

American Regent, Inc. is recalling three lots of epinephrine injection nationwide after customers reported vials that leaked or cracked, raising concerns that the sterile solution inside was no longer safe to use. The company, based in New Albany, Ohio, is pulling the product down to the consumer level, meaning pharmacies, clinics and patients who already have it are being asked to stop using it and return it.

This epinephrine injection recall does not touch the EpiPen or any other auto-injector that patients keep on hand for allergic emergencies. The recalled product is a 30 mL multi-dose vial of epinephrine injection, USP, at a concentration of 1 mg/mL, meant to be drawn up and given by a physician or under a physician's direction, intravenously, intramuscularly or under the skin. It stocks hospital carts and clinic supply rooms, where it treats severe allergic reactions, including anaphylaxis from insect stings, food, drugs and other triggers, and it is also used to raise blood pressure in adults in septic shock. If someone carries an EpiPen or similar device for allergies, that device is not affected and nothing about how they use it changes.

## Why American Regent Pulled the Lots

Customers complained of vials that were leaking or cracked, which raised doubt about whether the contents inside had stayed sterile. When American Regent looked into the reports, its investigation also turned up particulate matter in the solution, identified as nylon, cellulosic material, acrylic, polyethylene and glass.

The product is often given intravenously, straight into the bloodstream, which is what makes those particles dangerous. Particles injected into a vein can lodge in blood vessels and block them, cutting off blood flow to organs, or travel to the lungs and cause a pulmonary embolism, a blood clot that can be life-threatening. They can also irritate the vein where the injection is given, trigger an inflammatory reaction, worsen an existing infection, or set off an allergic reaction. A cracked vial carries a separate risk: a compromised seal can let in contamination even when no particles are visible. American Regent says it has not received any reports of patients harmed by the recalled vials.

The recall is listed on the U.S. Food and Drug Administration's drug recalls page, dated September 3, 2026, with the reason given as the presence of particulate matter and a lack of assurance of sterility.

## What Was Recalled and Who Should Act

The recall covers three lot numbers: 25128L1C0, expiring August 2026; 25280L1C0, expiring October 2026; and 26108L1C0, expiring July 2027. All carry NDC number 0517-3030-01 and were distributed across the United States between September 2025 and July 2026.

Because this is a clinical product, most people will never handle a vial directly. Hospitals, clinics and distributors that hold any of the three lots should stop using them right away and return the product to where they bought it, or discard it, and American Regent is contacting distributors and customers directly by letter to arrange returns and replacements. Patients are unlikely to have this vial at home, but anyone who was given epinephrine from a multi-dose vial during treatment, or who was separately prescribed one, should stop using it and call their doctor or healthcare provider with questions.

## FAQ

**Q: Is there a recall on epinephrine injection in 2026?**
Yes. American Regent is recalling three lots of its 30 mL, 1 mg/mL epinephrine injection multi-dose vials nationwide, after finding leaking and cracked vials and particulate matter in the solution.

**Q: Were there any EpiPen recalls?**
No. This epinephrine vial recall involves the multi-dose product used in hospitals and clinics, not the EpiPen or other auto-injectors that people carry for allergic emergencies. Those devices are not part of this action.

**Q: Why is particulate matter in an injectable drug dangerous?**
Particles injected into a vein can block blood vessels, cut off blood flow to organs, or cause a clot in the lungs. They can also irritate the injection site or trigger an allergic or inflammatory reaction.

**Q: What should I do if I have a recalled epinephrine vial?**
Stop using it. Hospitals, clinics and distributors should return or discard affected lots, and patients who received the product should contact their doctor or healthcare provider.