Epinephrine Injection Recall: American Regent Pulls Three Lots Nationwide Over Cracked Vials and Contamination Concerns

American Regent has issued a nationwide recall of three lots of injectable epinephrine after reports of cracked and leaking vials led to concerns about sterility. The company also found several types of foreign particulate matter inside affected vials, prompting a safety warning for health care providers and patients.

The U.S. Food and Drug Administration (FDA) published the voluntary recall notice on September 3, 2026. The recall involves Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials manufactured by American Regent Inc.

The recalled products were distributed across the United States. According to the FDA, the company received customer complaints involving leaking and cracked vials. Because damage to a vial can compromise the container and its seal, there is no longer assurance that the medication remains sterile.

American Regent's investigation also identified particulate matter in the affected medication. The materials included nylon, cellulosic material, acrylic, polyethylene and glass.

Which Epinephrine Lots Are Being Recalled?

The recall applies to three specific lots of Epinephrine Injection, USP. Consumers and health care facilities should check the lot number on their product rather than assuming that every epinephrine injection has been affected.

The recalled lots are:

• Lot 25128L1C0, with an expiration date of August 2026
• Lot 25280L1C0, with an expiration date of October 2026
• Lot 26108L1C0, with an expiration date of July 2027

The FDA states that the affected products were distributed nationwide. The product carries NDC 0517-3030-01. Distribution dates ranged from September 2025 through July 2026, depending on the lot.

The FDA's official recall notice provides additional product identification information, including the affected lot numbers and expiration dates.

Why Are Cracked Epinephrine Vials a Safety Concern?

Epinephrine is an emergency medication that can be used to treat severe allergic reactions, including anaphylaxis. Because injectable medications may be administered directly into the body, maintaining sterility is especially important.

A cracked or leaking vial can compromise the container that protects the medication from outside contamination. If the integrity of that container is damaged, the medication may no longer be considered reliably sterile.

The presence of foreign particles creates another potential concern. According to the FDA recall notice, intravenous administration of epinephrine containing particulate matter could result in serious health consequences.

Particles introduced into the bloodstream may potentially obstruct blood vessels. In severe circumstances, this could interfere with blood flow to vital organs and contribute to complications such as pulmonary embolism, permanent organ damage or death.

The FDA also notes that particulate matter could cause irritation of veins, inflammatory reactions, aggravation of existing infections or allergic reactions.

These risks are particularly concerning because epinephrine is often administered when a patient is already experiencing a serious medical emergency.

What Is Epinephrine Injection Used For?

Epinephrine, also known as adrenaline, is an important emergency medication.

The recalled injectable product is indicated for the emergency treatment of Type I allergic reactions, including anaphylaxis. Severe allergic reactions can occur after exposure to foods, medications, insect stings or bites, diagnostic substances and other allergens.

The product is also indicated for idiopathic anaphylaxis and exercise-induced anaphylaxis. According to the FDA, it can additionally be used to increase mean arterial blood pressure in adults experiencing hypotension associated with septic shock.

Epinephrine has several medical applications because it affects the heart, blood vessels and airways. It can increase blood pressure and heart rate while helping improve breathing during certain emergencies.

For anaphylaxis specifically, epinephrine is considered the first-line treatment. Cleveland Clinic notes that anaphylaxis can cause symptoms such as difficulty breathing, swelling, hives and a dangerous drop in blood pressure. Prompt treatment is critical because anaphylaxis can become life-threatening.

What Should Health Care Facilities Do With Recalled Products?

American Regent says distributors, retailers and health care facilities that have the affected vials should stop using the recalled products.

The company is notifying distributors and customers and arranging for recalled products to be returned or replaced. Facilities with affected inventory should follow the company's recall instructions and either return the product to the place of purchase or dispose of it according to applicable procedures.

Health care professionals should check their medication supplies carefully, particularly when epinephrine injection is stocked for emergency treatment.

Because the recall applies only to specified lots, checking the product's lot number is important. A health care facility should not assume that all injectable epinephrine products are included in the recall.

What Should Patients Do?

Patients who have been given or are using a recalled product should contact their doctor or other health care provider for guidance, according to American Regent's recall notice.

Patients should not make changes to prescribed emergency treatment without speaking with an appropriate health care professional. If someone has a severe allergic reaction, immediate emergency treatment remains critical.

Anaphylaxis can develop rapidly. Symptoms may include difficulty breathing, swelling of the lips, mouth or throat, widespread hives, dizziness, confusion, vomiting or signs of dangerously low blood pressure.

For people who use an epinephrine auto-injector during an anaphylactic reaction, Cleveland Clinic advises seeking emergency medical care immediately after using the medication because symptoms can return and additional treatment may be necessary.

It is important to note that the American Regent recall concerns specific 30 mg/30 mL multi-dose injectable vials. It does not mean that every epinephrine product or every epinephrine auto-injector has been recalled.

Has Anyone Been Injured?

As of the FDA's September 3 recall announcement, American Regent reported that it had not received any reports of adverse events associated with the recalled lots.

The recall is nevertheless significant because medication sterility and product quality are essential for injectable drugs, especially those used during medical emergencies.

The FDA maintains a public database of recalls, market withdrawals and safety alerts so patients and health care professionals can monitor official safety information.

How to Get More Information

Consumers and health care professionals with questions about the recall can contact American Regent's customer service department at 1-800-645-1706.

The company also provides separate contacts for adverse event reports, product quality complaints and medical information.

Potential adverse reactions or quality problems involving the product can also be reported through the FDA's MedWatch Adverse Event Reporting Program.

For the most accurate and current information, consumers should review the official FDA recall notice and consult their physician, pharmacist or other qualified health care professional.

Bottom Line

The American Regent epinephrine recall affects three lots of injectable epinephrine distributed nationwide in the United States. The recall was initiated after reports of cracked and leaking vials raised concerns about sterility, while the manufacturer's investigation identified foreign particulate matter including nylon, acrylic, polyethylene, cellulosic material and glass.

Although no adverse events had been reported to the company as of the recall announcement, the potential consequences of contaminated injectable medication can be serious.

Anyone who has access to the affected product should check the lot number, stop using recalled inventory and follow guidance from American Regent and health care professionals regarding return or replacement.

The recall is a reminder that patients and medical facilities should regularly check medication lot numbers and expiration dates and stay informed about official drug safety alerts.

Sources:
U.S. Food and Drug Administration, American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL).

Disclaimer: This article is intended for general informational and educational purposes only. It is not medical advice and does not replace guidance from a doctor, pharmacist or other qualified health care professional. Medication recalls and safety recommendations can change as new information becomes available. Readers should verify recall information through the FDA and the manufacturer and should seek professional medical advice about their individual circumstances. In a suspected anaphylactic emergency, seek emergency medical assistance immediately.