[1/16/2025] FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. Health care professionals have confused these products with FDA-approved injectable epinephrine products for intravenous use. BPI Labs and Endo USA nasal solutions products should never be injected intravenously.
The nasal solution and injectable products have similar packaging and containers and are manufactured by the same companies. The similarities of the bottle and packaging labels between the nasal product and the sterile injectable make it difficult to distinguish them from each other which can lead to health care professionals accidentally injecting the nasal solution instead of the injection product.
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.
Health care professionals use both products in hospitals and health care settings.
Figure 1: Left images: BPI Labs’ FDA-approved Epinephrine Injection with blue lid on the bottle
Right images: BPI Labs’ unapproved EPINEPHrine Chloride Nasal Solution with red lid on the bottle
Photograph submitted to FDA via an adverse event report
Figure 2: Left images: BPI Labs recently updated its label and packaging. The new unapproved EPINEPHrine Chloride Nasal Solution with a red bottle lid and maroon label in a maroon box.
Right images: BPI Labs’ FDA-approved Epinephrine Injection with blue lid on the bottle and purple highlight on the bottle and package.
Photograph provided to FDA by BPI Labs
Figure 3: Left images: Endo USA’s unapproved Adrenalin Chloride (epinephrine) nasal solution, labeled as Par Pharmaceuticals, with a blue lid on the bottle
Right images: Endo USA’s FDA-approved Adrenalin (epinephrine) injection, labeled as Par Pharmaceuticals, with red lid on the bottle.
Photograph submitted to FDA via an adverse event report
Endo USA voluntarily recalled on Dec. 20, 2024, its unapproved Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) due to the potential for health care professionals accidentally injecting the nasal solution instead of the injection product.
FDA recommended BPI Labs recall its unapproved EPINEPHrine Nasal Solution on Dec. 12, 2024. The agency followed up with the company several times to reiterate this recommendation. The latest adverse event report FDA received involved the product with BPI Labs’ most recently revised label (figure 2, left images). The company has not acted to remove its unapproved drug from the market.
FDA has received more than 25 reports since 2016 stating confusion between unapproved epinephrine nasal solution and approved epinephrine injection involving similarities in product labels and containers. Recently in 2024, the agency received a report involving a patient who received the nasal solution as an injection.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program:
