Epinephrine Nasal Solution - FDA Warning

On Jan. 16, 2025, the FDA warned healthcare professionals not to use unapproved epinephrine nasal solutions from BPI Labs and Endo, as they have been confused with FDA-approved injectable epinephrine for intravenous use. Unlike an injectable drug, nasal solutions are not required to be sterile. Injecting a non-sterile drug can lead to infection, which can be life-threatening for certain patients. FDA has received more than 25 reports since 2016 stating confusion between unapproved epinephrine nasal solutions and approved epinephrine injections involving similarities in product labels and containers. In December 2024, the manufacturer issued a recall of certain lots of epinephrine nasal solution to the consumer level. More information regarding this recall can be found at https://content.govdelivery.com/accounts/USFDA/bulletins/3cd2fc9