American Regent Recalls 3 Epinephrine Injection Lots Over Particulate Matter, Sterility Concerns

American Regent, Inc has issued a voluntary nationwide recall of 3 lots of epinephrine injection, USP 30 mg/30 mL (1 mg/mL) multidose vials, after fielding customer complaints of leaking and cracked vials. The affected lots—25128L1C0, 25280L1C0, and 26108L1C0, all under National Drug Code 0517-3030-01—were distributed across the US between September 2025 and July 2026, with expiration dates ranging from August 2026 to July 2027. The company's investigation into the complaints also turned up particulate matter inside the vials, including nylon, cellulosic material, acrylic, polyethylene, and glass.¹

Why the Recall Was Issued

The dual findings—compromised vial integrity and visible particulate contamination—triggered the action. Cracked vials cannot maintain a sterile barrier, opening the door to microbial contamination, while particulate matter poses a distinct and serious risk when the drug is administered intravenously (IV). According to the recall notice, particulates introduced into the bloodstream can cause vascular blockage and clotting, cut off blood flow to vital organs, precipitate a life-threatening pulmonary embolism, and cause permanent organ damage or death. Localized risks include vein irritation, inflammatory reaction, and allergic response. As of the recall announcement, American Regent reported no adverse events (AEs) tied to the affected lots.¹

Notably, this is the third injectable recall tied to American Regent in about 6 weeks, and glass particulate has surfaced in each one—first in a papaverine hydrochloride injection lot, then in Adequan injections for dogs and horses, and now in this epinephrine recall. The recurring finding across product lines raises questions about a shared upstream manufacturing or supply issue, even though no single cause has been publicly confirmed.²

Scope of Distribution and Next Steps

The 30 mL multidose vials are used via an IV, intramuscularly, or subcutaneously under physician direction. American Regent is notifying distributors and customers by letter and coordinating returns and replacements. Distributors, retailers, and health care facilities holding affected stock should stop using it and either return it to the point of purchase or discard it. Patients who are using the product are advised to stop and contact their health care provider with any concerns. AEs or quality complaints can be reported to the FDA's MedWatch program or directly to American Regent's pharmacovigilance line.^1,3

Clinical Role of Epinephrine

Epinephrine injection is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis triggered by insect stings, foods, drugs, or other allergens, as well as idiopathic or exercise-induced anaphylaxis, and to raise mean arterial pressure in adults with septic shock–associated hypotension. As a nonselective alpha- and beta-adrenergic agonist, epinephrine also has a longstanding, if now secondary, role in respiratory care: It produces bronchodilation through beta-2 receptor activity and was historically used to relieve acute bronchospasm, including asthma exacerbations, before the development of selective inhaled beta-agonists made those agents the preferred first-line bronchodilators.^1,4

Today, epinephrine's respiratory use is largely confined to severe, anaphylaxis-associated bronchospasm rather than routine asthma management, but it remains a critical rescue option when airway compromise is part of a broader systemic allergic response.^1,4

What Pharmacists Should Know

Given epinephrine's role as an emergency, often crash-cart or code-cart medication, pharmacists and health systems should reconcile current inventory against the 3 affected lot and NDC numbers without delay. Because the drug is frequently stocked in bulk multidose vials for anaphylaxis and shock protocols, verifying stock proactively—rather than waiting for a use-related complaint—is especially important in this case. Pharmacists should also remain alert for similar particulate-related complaints in other American Regent injectable products, given the pattern identified across the company's recent recalls, and should encourage front-line staff to visually inspect vials for cracks or particulate matter before use, consistent with standard practice for all injectable products.

REFERENCES

1. American Regent, Inc. American Regent, Inc. issues voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) due to the presence of particulate matter and lack of assurance of sterility. U.S. Food and Drug Administration. September 3, 2026. Accessed September 9, 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30

2. Vega E. Three American Regent injectable recalls in roughly six weeks share one common finding, and it is glass. Medical Daily. September 8, 2026. Accessed September 9, 2026. https://www.medicaldaily.com/american-regent-glass-particulate-recalls-epinephrine-papaverine-adequan-478343

3. Kaplan Z. Epinephrine injection recalled by American Regent over health risks: FDA. The Hill. September 4, 2026. Accessed September 9, 2026. https://thehill.com/policy/healthcare/6071686-epinephrine-injection-recalled-fatal-health-risk-fda/

4. Dalal R, Grujic D. Epinephrine. In: StatPearls. StatPearls Publishing; Updated November 23, 2024. Accessed September 9, 2026. https://www.ncbi.nlm.nih.gov/books/NBK482160/