FDA Recalls · September 3, 2026 · Primary source
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
Summary
American Regent, Inc. issued a voluntary nationwide recall on September 3, 2026, covering three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials due to customer reports of leaking and cracked vials, raising concerns about particulate matter and lack of sterility assurance. The recall extends to the consumer level. Epinephrine is a critical emergency medication used across hospital, ASC, and long-term care settings.
What this may mean
Facilities holding the recalled lots must remove them from use; the recall affects hospitals, ASCs, SNFs, and other settings that stock multi-dose epinephrine vials. The sterility and particulate concerns create patient-safety risk and potential liability exposure for facilities that dispensed affected lots.
Informational only. Not legal, medical, financial, or other professional advice. Always consult a qualified professional familiar with your specific facts before relying on any item.
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