FDA classifies American Regent epinephrine recall as most serious after cracked, contaminated vials

American Regent, Inc. has recalled three lots of injectable epinephrine nationwide after customers reported vials that were cracked or leaking, a defect the company says compromised sterility and let stray particles of nylon, cellulosic fiber, acrylic, polyethylene and glass into the medication. The Food and Drug Administration has classified the action as a Class I recall, its most serious designation, reserved for situations in which continued use of a product could cause serious injury or death.

The recalled drug is Epinephrine Injection, USP, 30 mg/30 mL (1 mg/mL), sold in multi-dose vials under NDC 0517-3030-01. It is the concentrated, hospital-grade formulation that pharmacists dilute for use in operating rooms, emergency departments, code carts and ambulances — a different product from the single-dose EpiPen-style auto-injectors that allergy patients carry for anaphylaxis, though both rely on the same drug.

What the recall covers

American Regent, based in Shirley, New York, said the affected vials were manufactured at a plant in New Albany, Ohio, and distributed across the United States over roughly a ten-month span. Three lots are involved: 25128L1C0, distributed between September 4 and December 18, 2025, and set to expire this month; 25280L1C0, distributed from mid-December 2025 through mid-April 2026, expiring in October; and 26108L1C0, distributed from mid-June through July 31, 2026, with a July 2027 expiration date. All three were sold to the consumer level, meaning they reached hospitals, clinics, pharmacies and other end users rather than stopping at a wholesale distribution point.

The company said the recall began after it received customer complaints describing leaking and cracked vials. A subsequent internal investigation identified particulate contamination in the affected lots. Because the epinephrine in these vials is most often given intravenously in acute settings — for anaphylactic shock, cardiac arrest or severe allergic reactions — the company and the FDA warned that injecting fluid carrying foreign particles poses a distinct danger.

"Intravenous administration of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) containing particulate matter may lead to serious adverse health consequences," American Regent said in its recall notice posted to the FDA's website.

The company elaborated that such particles can block or clot blood vessels, cutting off circulation to vital organs, cause a potentially fatal pulmonary embolism, or trigger permanent organ damage. Vials that lose their seal integrity also risk microbial contamination, adding a second sterility hazard on top of the visible particulate matter. As of the recall's announcement, American Regent said it had not received any reports of adverse events tied to the affected lots.

A manufacturer's third recall since July

The epinephrine recall is the third nationwide action American Regent has taken in about six weeks. On July 24 the company recalled a single lot of papaverine hydrochloride injection, used to treat vascular spasm, after finding glass and paraformaldehyde particles in the product. A week later, on July 31, its animal-health division recalled four lots of Adequan, an injectable joint medication for dogs and horses, after glass fiber material turned up in retained samples. Neither of those recalls has been linked to reported patient or animal harm, but together with the epinephrine recall they point to a recurring quality-control problem at a manufacturer that supplies a meaningful share of the sterile injectable drugs used in American hospitals.

Particulate contamination is not unique to American Regent. Industry trackers have long identified foreign material — glass shards from ampule breakage, rubber or plastic fragments from stoppers and seals, fibers shed during filling — as one of the most common triggers for sterile-injectable recalls industrywide, a byproduct of the high-speed aseptic manufacturing lines used to fill millions of small-volume vials. What distinguishes this case is the drug involved: epinephrine has no substitute in a true anaphylactic or cardiac emergency, and its multi-dose hospital vials have already been through periodic shortages in recent years, including an earlier, less severe Class II recall of an American Regent epinephrine lot last spring over separate sterility concerns.

Who is affected

Because the recalled vials are the multi-dose, hospital-administered formulation rather than take-home auto-injectors, the recall's most direct effect falls on hospitals, surgical centers, urgent-care clinics, ambulance services and the pharmacies that supply them, rather than on individual allergy patients checking their EpiPens at home. Facilities that received any of the three lots are being told to stop using them immediately and to quarantine remaining stock for return or destruction. Patients who received an injection from one of the affected lots, or family members concerned about a dose administered in a clinical setting, are advised to contact the treating facility or their physician with questions, since the drug itself — as opposed to the vial defect — is not in question.

The timing adds pressure for some facilities. Epinephrine auto-injectors have faced intermittent shortages over the past two years, and hospital pharmacies have at times leaned more heavily on multi-dose vials, which they dilute into pre-filled syringes, to keep code carts and crash trolleys stocked. A recall that pulls three lots of that same vial format off shelves — even temporarily, while unaffected lots remain available — tightens an already thin margin for a drug hospitals cannot safely go without.

What happens next

American Regent has set up dedicated lines for the recall: a product-quality complaint line at 1-888-354-4855 or by email, and a pharmacovigilance line at 1-800-734-9236 for providers who suspect a patient was affected. Health care providers and consumers are also being directed to report any adverse events tied to the recalled lots through the FDA's MedWatch safety reporting program, either online or by calling 1-800-332-1088. Distributors and retailers that received the affected lots are being instructed to notify their own customers and arrange for returns.

The FDA's Class I designation means the agency will continue monitoring the recall's execution and any adverse-event reports that come in through MedWatch, while American Regent works through its distribution network to retrieve unused vials before their printed expiration dates pass. Neither the company nor the FDA has said whether the three back-to-back-to-back recalls will trigger a broader facility inspection, though repeated particulate findings across different product lines within the same six-week window are the kind of pattern that regulators and hospital purchasing departments alike tend to scrutinize closely. For now, the practical instruction to hospitals and clinics holding any of lots 25128L1C0, 25280L1C0 or 26108L1C0 is unchanged: stop using the product, secure it, and wait for confirmation before restocking with epinephrine from the same source.