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A medication used for the emergency treatment of a life-threatening allergic reaction is being recalled over concerns of sterility and the possible presence of particulate matter.
Ohio-based American Regent Inc. is conducting a nationwide recall of three lots of its Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials.
Epinephrine is used to emergently treat life-threatening allergic reactions, such as anaphylaxis, which can be caused by insect stings, foods or medications.
It can also be used to increase blood pressure in critically ill patients suffering from life-threatening septic shock.
The recall was initiated after the company received complaints from consumers detailing leaking and cracked vials, which resulted in the lack of assurance of sterility.
An investigation then revealed the presence of particulate matter identified as nylon, cellulose, acrylic, polyethylene and glass.
The FDA warns that intravenous administration of an epinephrine injection containing particulate matter could lead to ‘serious adverse health consequences.’
Epinephrine is used to emergently treat life-threatening allergic reactions, such as anaphylaxis, which can be caused by insect stings, foods or medications (stock image)
The recalled Lot Numbers are 25128L1C0, 25280L1C0 and 26108L1C0, and the injections were distributed nationwide
The FDA recall notice stated: ‘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.
‘Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions.
‘Additionally, 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.’
No adverse events have been reported in connection to the recall.
The recalled lots have expiration dates of August 2026, October 2026 and July 2027.
They were distributed to patients beginning in September 2025 through July 2026.
The affected Lot Numbers are 25128L1C0, 25280L1C0 and 26108L1C0, and they were distributed nationwide.
In the US, anywhere from 3.4 million to 17 million Americans suffer from anaphylaxis per year and 225 people die from it. Meanwhile, about 1.7 million adults develop sepsis each year and at least 350,000 die from it.
