The U.S. Food and Drug Administration (FDA) recently announced that the manufacturer American Regent is voluntarily recalling three lots of epinephrineEpinephrine Also called adrenaline, this hormone is used in emergency situations to reverse symptoms during a severe allergic reaction (anaphylaxis). injection multidose vials nationwide due to findings of cracked and leaking containers with particle contamination. The recall involves multidose vials used primarily in healthcare settings — not epinephrine autoinjectors, such as the EpiPen, that many people with systemic mastocytosis (SM) carry to treat severe allergic reactions.
American Regent announced the recall on Sept. 3, 2026, for Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multidose vials from three lots — 25128L1C0, 25280L1C0 and 26108L1C0 — that were distributed nationwide. The company acted after customers reported leaking and cracked vials, which can compromise sterility. The company’s investigation of the vials found particles including nylon, glass, acrylic and polyethylene.
According to the FDA notice, “particulate matter can cause blockage and clotting in blood vessels,” a significant danger when the drug is delivered intravenously. The particles could also irritate veins, spark inflammation, worsen an existing infection or trigger an allergic reaction. American Regent said it had received no reports of harm linked to the recall.
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Epinephrine is the first-line emergency treatment for anaphylaxisAnaphylaxis A severe allergic reaction that can turn fatal without treatment. Patients with SM are at a higher risk of developing anaphylaxis., a rapid, life-threatening allergic reaction that can be triggered by insect stings or bites, foods, medications and other allergens. People with systemic mastocytosisMastocytosis Rare disease caused by the buildup of mast cells. Cutaneous mastocytosis primarily affects the skin and is more common in children, while systemic mastocytosis affects internal organs and is more common in adults. are at increased risk of anaphylaxis.
Epinephrine multidose vials require a trained provider to draw the appropriate dose of the medication into a syringe before injecting it, and they are generally stocked in hospitals, clinics and ambulances. This is different from an autoinjector like an EpiPen, which delivers a single, preset dose when pressed against the thigh and is designed for patients or caregivers to use in an emergency.
American Regent is contacting its distributors and customers by letter to arrange returns and replacements for the recalled lots. Pharmacies, retailers and healthcare facilities that stock the affected product should stop using it and either send it back to where they bought it or dispose of it. Patients who have had any problems they think may be linked to the drug should reach out to their physician or healthcare provider.
Read more about epinephrine autoinjectors: “Living with systemic mastocytosis: How to store and carry your EpiPen”
