American Regent recalls 3 lots of epinephrine injection over particulate matter and cracked vials

American Regent, Inc. is recalling 3 lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multidose vials nationwide after customer complaints of leaking and cracked vials, according to a company announcement published by the FDA on September 3, 2026.¹

The recall extends to the consumer level and covers lot numbers 25128L1C0 (expiration August 2026), 25280L1C0 (expiration October 2026), and 26108L1C0 (expiration July 2027), all under NDC 0517-3030-01. The lots were distributed nationwide between September 4, 2025, and July 31, 2026.

According to the announcement, the complaints resulted in a "lack of assurance of sterility." The company's investigation also identified particulate matter in the product, including nylon, cellulosic, acrylic, polyethylene, and glass particles.

American Regent said intravenous administration of the affected product could lead to serious adverse health consequences. Particulate matter can block blood vessels and cause clotting, which may cut off blood flow to vital organs, lead to pulmonary embolism, and cause permanent organ damage or death, according to the company. The particles also may cause local vein irritation, inflammatory reactions, aggravation of preexisting infections, and allergic reactions. In addition, the company said, "cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients."

As of the announcement, American Regent had not received any reports of adverse events related to the recall.

What veterinary teams should know

The recalled product is a clear, colorless, sterile solution labeled for human use. Its approved indications include emergency treatment of type I allergic reactions, including anaphylaxis, and increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock.¹ Epinephrine also is used in veterinary emergency medicine, including during cardiopulmonary resuscitation and in the treatment of anaphylaxis.

The announcement does not specify whether the affected lots reached veterinary practices. Hospitals that stock the American Regent 30-mL multidose vial should check crash carts and pharmacy inventory against the recalled lot numbers.

"Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product," American Regent said in the announcement. The company is notifying distributors and customers by letter and arranging for return or replacement of all recalled products.

The recall is being conducted with the knowledge of the FDA. Questions about the recall can be directed to American Regent customer service at 1-800-645-1706, Monday through Thursday from 8 AM to 6 PM ET and Friday from 8 AM to 4 PM ET. Adverse events can be reported to the company's pharmacovigilance department at 1-800-734-9236 or [email protected], or to the FDA's MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.

Second American Regent recall this summer

The epinephrine recall comes about 5 weeks after American Regent Animal Health, a division of American Regent, Inc., announced a nationwide recall of 4 lots of Adequan products on July 31, 2026, after glass fibers were detected during testing of retained samples.²

That recall included Adequan Canine Injection (100 mg/mL, 5-mL multidose vials), lot numbers 3369 and 25011, and Adequan i.m. Injection (500 mg/5 mL, single-dose 5-mL vials), lot numbers 24416 and 25265P. According to the company, administering an intramuscular product containing glass fibers may cause injection-site pain, local irritation, swelling, inflammation, infection, or abscess formation. No adverse events had been reported at the time of that announcement.

Veterinary hospitals, clinics, and other consignees with the recalled Adequan lots were advised to stop distributing the products and either return remaining inventory to the manufacturer or discard it.²

References

1. 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. News release. US Food and Drug Administration. September 3, 2026. Accessed September 11, 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. Bautista-Alejandre A. Adequan injections for dogs and horses recalled nationwide after glass fibers detected. dvm360. August 3, 2026. Accessed September 11, 2026. https://www.dvm360.com/view/adequan-injections-for-dogs-and-horses-recalled-nationwide-after-glass-fibers-detected