Particulate Matter Risk Prompts American Regent Epinephrine Recall 2026

A medication meant to reverse a life-threatening allergic reaction is now the subject of a nationwide recall after patients and pharmacies flagged vials that were leaking, cracked, and contaminated with foreign material. American Regent, Inc. announced on September 3, 2026, that it is voluntarily pulling three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi dose vials from the consumer level across the United States.

The New Albany, Ohio-based drugmaker said the action follows customer complaints about vials that had cracked or begun leaking, raising concerns that the sterile barrier had been compromised. A company investigation into the complaints went further, turning up particulate matter inside the solution identified as nylon, cellulosic material, acrylic, polyethylene and glass.

Recalled Products at a Glance

The recall covers Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL), sold under NDC 0517-3030-01. Three specific lots are involved, each distributed to pharmacies and healthcare facilities nationwide over different windows:

• Lot 25128L1C0 — expires August 2026; distributed September 4, 2025 through December 18, 2025
• Lot 25280L1C0 — expires October 2026; distributed December 16, 2025 through April 17, 2026
• Lot 26108L1C0 — expires July 2027; distributed June 15, 2026 through July 31, 2026

What Went Wrong?

Epinephrine Injection, USP is typically given intravenously, intramuscularly or subcutaneously by or under the direction of a physician to treat severe allergic reactions, including anaphylaxis triggered by insect stings, foods, drugs or other allergens. It’s also used to raise blood pressure in adult patients experiencing hypotension linked to septic shock.

When administered intravenously, the company warned, particulate matter in the injection can cause blockage and clotting in blood vessels. That can cut off blood flow to vital organs, trigger a life-threatening pulmonary embolism, and cause permanent organ damage or death. The particles may also cause vein irritation, inflammatory reactions, aggravation of existing infections and allergic reactions. Separately, cracked vials threaten the product’s sterility altogether, opening the door to contamination.

As of the announcement, American Regent said it had not received any reports of adverse events tied to the affected lots.

Who Should Be Concerned

Because the three lots were shipped nationwide, this recall touches hospitals, clinics, pharmacies and any patient or caregiver who keeps this emergency medication on hand. Distributors, retailers and healthcare facilities holding any of the listed lot numbers are directly affected, as are individual patients who received the product through a healthcare provider.

What Consumers Need to Do Now

Anyone in possession of the recalled vials should stop using them right away. The company outlined the following steps:

• Distributors, retailers and healthcare facilities should stop using the product and return it to the place of purchase or discard it
• Patients using the recalled product should stop and contact their doctor or healthcare provider
• Anyone who has experienced a problem possibly related to this product should contact their physician
• Adverse events or quality issues can be reported to the FDA’s MedWatch program online or by mail/fax

American Regent is notifying its distributors and customers by letter and is arranging for the return or replacement of the recalled product. Consumers and healthcare professionals with questions can reach the company’s customer service line at 800-645-1706 (8:00 AM–6:00 PM EST Monday through Thursday, 8:00 AM–4:00 PM EST Friday) for return, replacement or credit information. Adverse events can be reported to pharmacovigilance at 800-734-9236 or pv@americanregent.com, while product quality complaints go to 888-354-4855 or pqc@americanregent.com.

What the Company Said

‘American Regent, Inc. is committed to the safety of patients who rely on its products and is taking this action to protect public health,’ the company said in its announcement. The FDA noted the recall is being carried out with its knowledge, though the agency does not endorse either the product or the company when publishing a firm’s own recall notice.