TL;DR: Three lots of American Regent epinephrine vials are under nationwide recall.

TL;DR: American Regent, Inc. is conducting a nationwide voluntary recall to the consumer level of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) in multi-dose vials because of leaking and cracked vials, lack of assurance of sterility, and particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass.

The action was announced for immediate release on September 3, 2026, from New Albany, Ohio, according to the U.S. Food and Drug Administration recall notice. The FDA notice states that the agency posts company announcements as a public service and does not endorse either the product or the company. The company announcement carried by PR Newswire contains the same September 3, 2026 date, location, product description, lot information and risk language.

For households, clinics, response teams and emergency caches that store injectable allergy and shock medication, the message is direct: identify the listed vials, do not administer them, and follow the return and medical-contact instructions in the announcement.

What product is under recall

The recall covers Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) packaged in multi-dose vials, according to the U.S. Food and Drug Administration recall notice.

The product is described as a clear, colorless, sterile solution supplied in a 30 mL multiple-dose vial containing 1 mg/mL. The listed National Drug Code is 0517-3030-01. The brand name listed in the summary is American Regent, Inc.

The announcement states that the vials are administered intravenously, intramuscularly, or subcutaneously and are to be used by or under the direction of a physician. That direction defines who is expected to handle the drug and under what supervision.

The recall is described as nationwide and to the consumer level. The affected lots were distributed nationwide in the United States. American Regent stated that it is notifying distributors and customers by letter and arranging for return, replacement and related handling of all recalled products.

The three affected lots, expiry dates and distribution windows

Only three lots are listed in the recall table. All three share the same product name and NDC, but each has a separate lot number, expiry and distribution period.

Lot 25128L1C0 carries an expiry of August 2026. Its listed distribution date range began September 04, 2025 and ended December 18, 2025.

Lot 25280L1C0 carries an expiry of October 2026. Its listed distribution date range began December 16, 2025 and ended April 17, 2026.

Lot 26108L1C0 carries an expiry of July 2027. Its listed distribution date range began June 15, 2026 and ended July 31, 2026.

Anyone reviewing a medicine cabinet, clinic refrigerator, ambulance stock, preparedness bin or backup medical tote should compare both the NDC and the lot code on the vial label against that table. The announcement presents NDC 0517-3030-01 for each of the three entries, so the lot code is the key distinction among them.

The beginning and ending distribution dates matter for retrospective checks. A vial obtained during the September 2025 through December 2025 interval could correspond to the first listed lot. A vial obtained during the December 2025 through April 2026 interval could correspond to the second listed lot. A vial obtained during the June 2026 through July 2026 interval could correspond to the third listed lot.

Expiry alone does not clear a vial. The first lot shows August 2026, the second shows October 2026, and the third shows July 2027. A vial that remains within expiry but bears one of the three lot numbers is included in the described recall scope.

Why American Regent initiated the recall

The company said customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

Its investigation also revealed the presence of particulate matter. The particles were identified as nylon, cellulosic, acrylic, polyethylene and glass.

The stated reason for the announcement is presence of particulate matter and lack of sterility assurance. The company announcement carried by PR Newswire uses the same causal sequence of complaints, container defects, sterility uncertainty and laboratory identification of particle types.

Leaking and cracking are container-integrity failures. The announcement links those failures to loss of sterility assurance rather than to ordinary handling marks. That distinction is important for emergency planners who routinely inspect glass vials for chips, hairline fractures, loose caps or moisture around seals.

The identification of five particle categories indicates more than one material was detected during the firm's investigation. The listed materials are nylon, cellulosic, acrylic, polyethylene and glass. The announcement does not state that every vial contains all five materials. It states that the investigation revealed particulate matter identified under those categories.

Health risks described in the announcement

The risk statement focuses first on intravenous administration of Epinephrine Injection containing particulate matter. It states that such administration may lead to serious adverse health consequences.

Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs. The statement further lists a life-threatening blood clot in the lungs, described as pulmonary embolism, along with permanent organ damage or death.

Additional listed effects include local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. Those outcomes are presented as additional consequences associated with particles in an intravenously administered product.

Separately, cracked vials can compromise the integrity of the container, resulting in loss of sterility and potential contamination. The announcement states that this condition can pose a serious risk for patients.

To date, American Regent has not received any reports of adverse events related to this recall. That status reflects reports received by the company at the time of the September 3, 2026 announcement.

What the drug is used for and why continuity matters

Epinephrine Injection, USP is indicated for the emergency treatment of allergic reactions classified as Type I, including anaphylaxis. Listed triggers include insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

The product is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. That second indication places the same vial in both allergy-response and critical-care contexts.

Because the listed indications involve time-sensitive emergencies, the announcement's instruction to stop using recalled vials creates a replacement need. Facilities and individuals relying on the 30 mg/30 mL multi-dose presentation are directed to contact a physician or health care provider for guidance rather than continuing with a recalled lot.

The announcement does not direct consumers to substitute another concentration, presentation or manufacturer on their own. It directs patients that use the recalled product to stop using it and contact their doctor or health care provider.

What distributors, facilities and patients are directed to do

Distributors, retailers and health care facilities that hold product subject to the recall should stop using it and return it to the place of purchase or discard it. That instruction appears in both the U.S. Food and Drug Administration recall notice and the company announcement carried by PR Newswire.

American Regent stated that it is notifying distributors and customers by letter. The company also stated that it is arranging for return, replacement and related handling of all recalled products.

Patients that use the recalled product should stop using it and contact their doctor or health care provider. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using the drug product.

Consumers and health care professionals with questions about the recall can contact American Regent using the contact centers below. Customer Service handles detailed return, replacement and credit information at 800-645-1706, available 8:00AM to 6:00PM EST Monday through Thursday and 8:00AM to 4:00PM EST Friday.

Pharmacovigilance handles adverse-event reports at 800-734-9236 and [email protected]. Product Quality Complaints handles quality issues at 888-354-4855, available 9:00AM to 5:00PM EST Monday through Friday, and [email protected]. Medical Information handles medical questions at 888-354-4855 during the same weekday hours and [email protected].

How to report problems to FDA MedWatch

Adverse reactions or quality problems experienced with use of the product may be reported to FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.

Reports can be completed and submitted online at www.fda.gov/medwatch/report.htm. A form can be downloaded at www.fda.gov/MedWatch/getforms.htm, or a reporting form can be requested by calling 1-800-332-1088, then completed and returned to the address on the pre-addressed form or submitted by fax to 1-800-FDA-0178.

The announcement states that the recall is being conducted with the knowledge of the U.S. Food and Drug Administration. American Regent stated that it is committed to the safety of patients who rely on its products and is taking the action to protect public health.

Sources referenced