A medication used to reverse life-threatening complications has been recalled over contamination concerns.
Videos by Wide Open Country
What Medication Has Been Recalled?
The specific name of the medication is called epinephrine - you might know it as a brand name, Epi-Pen. According to the Cleveland Clinic, it is used to treat a number of complications, including cardiac arrest, septic shock, asthma, and anaphylaxis from allergic reactions.
The recall notice specifically named American Regent, Inc. of New Albany, Ohio, as the affected company. More specifically, their USP 30mg / 30mL (1mg/mL) multi-dose vials have been recalled.
The details of the recalled products are as follows, per the FDA:
| Product | NDC | Lot | Expiry | Distribution Date Range | |
| Beginning | End | ||||
| Epinephrine Injection, USP | 0517-3030-01 | 25128L1C0 | August 2026 | September 04, 2025 | December 18, 2025 |
| 25280L1C0 | October 2026 | December 16, 2025 | April 17, 2026 | ||
| 26108L1C0 | July 2027 | June 15, 2026 | July 31, 2026 | ||
What is Wrong With the Product?
The FDA explained that there may be issues with sterility, as well as possible particulate matter present within the vials. Consumers identified leaking and cracked vials, meaning the medication may not be sterile - however, an investigation by American Regent found possible particulate matter.
The specific particles with a possible presence in the medication are nylon, cellulosic, acrylic, polyethylene, and also glass.
The FDA gives the following risk factors if someone were to inject the recalled medication: "Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs and cause permanent organ damage or death."
They also added that "cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients."
What Should I Do if My Product is Affected?
The FDA has advised consumers affected by this recall to contact American Reagent - they can do this at their customer line, pharmocovigilance line, product quality complaints line, and also their medical information line, as shown in the table below:
| Contact Center | Contact Information | Area of Support |
| American Regent, Inc. Customer Service | Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday - Thursday, 8:00AM- 4:00PM EST, Friday) | For detailed return/replacement/credit information |
| American Regent, Inc. Pharmacovigilance | Phone: 800-734-9236 Email: [email protected] | To report adverse events |
| American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday - Friday) Email: [email protected] | For product quality complaints |
| American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday - Friday) Email: [email protected] | For medical questions |
