FDA announces nationwide recall of epinephrine injections over sterility and particulate concerns
A nationwide voluntary recall of three lots of Epinephrine Injection has been issued due to the “presence of particulate matter and lack of sterility assurance,” according to the U.S. Food and Drug Administration.
The FDA on Thursday shared a recall notice from Ohio-based American Regent stating that some Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi-dose vials were being recalled after the company received customer complaints “for leaking and cracked vials, resulting in lack of assurance of sterility.”
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The firm’s investigation also revealed “the presence of particulate matter identified as nylon, cellulosic, acrylic, polyethylene, and glass” in the product, the recall announcement states.
The epinephrine injections are meant to be used for “the emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis,” the company said in a risk statement attached to the recall notice. The notice goes on to state that “Epinephrine Injection, USP is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.”
The affected Epinephrine Injection, USP products were distributed nationwide in the United States and carry an NDC number of 0517-3030-01.
Lot Numbers 25128L1C0, 25280L1C0, and 26108L1C0 were distributed nationwide in the United States.
Here are the specific lot numbers, expiration dates, and distribution dates:
Lot: 25128L1C0Expiry: August 2026 Distribution date range: Sept. 04, 2025 to Dec. 18, 2025Lot: 25280L1C0Expiry: October 2026Distribution date range: Dec. 16, 2025 to April 17, 2026Lot: 26108L1C0Expiry: July 2027Distribution date range: June 15, 2026 to July 31, 2026
American Regent said that as of Sept. 3, it had not received any reports of adverse events related to this recall.
In its risk statement, American Regent said that intravenous administration of a product containing particulate matter can 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, lead to a life-threatening blood clot in the lungs (pulmonary embolism), and cause permanent organ damage or death,” the company wrote, adding that the particles “may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions.”
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.”
What to do if you have an impacted product
American Regent said it is notifying distributors and customers by letter and is arranging for the return or replacement of all recalled products.
Patients who use the product being recalled should stop using it and contact their doctor or health care provider, the company said in the notice.
Consumers and healthcare professionals with questions regarding the recall can contact American Regent. The contact information can be found below:
Contact Center
Contact Information
Area of Support
American Regent, Inc. Customer Service
Phone: 800-645-1706 (8 a.m.-6 p.m. EST, Monday – Thursday, 8 a.m. -4 p.m. EST, Friday)
For detailed return/replacement/credit information
American Regent, Inc. Pharmacovigilance
Phone: 800-734-9236 Email: pv@americanregent.com
To report adverse events
American Regent, Inc. Product Quality Complaints
Phone: 888-354-4855 (9 a.m. -5 p.m. EST, Monday – Friday) Email: pqc@americanregent.com
For product quality complaints
American Regent, Inc. Medical Information
Phone: 888-354-4855 (9 a.m.-5 p.m. EST, Monday – Friday)Email: ma@americanregent.com
For medical questions