FDA issues warning against using epinephrine nasal solutions from BPI Labs, Endo USA

The FDA has advised health care professionals that they should not use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC and Endo USA.

The FDA noted that health care professionals have confused these products with approved injectable epinephrine products designed for intravenous use, adding that these nasal solution products should never be injected intravenously.

These companies produce nasal solution and injectable products with similar packaging and containers that are difficult to distinguish from each other, the FDA warned, which may lead health care professionals to use the nasal solution in their injections.

Further, the FDA said that injectable solutions must be sterile, but nasal solutions do not share this requirement. Injecting nonsterile drugs may lead to infections, which may be life-threatening for some patients, the FDA continued.

On Dec. 20, 2024, Endo USA voluntarily recalled its unapproved Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) because of these risks for accidental injection.

On Dec. 12, 2024, the FDA recommended that BPI Labs recall its unapproved EPINEPHrine Nasal Solution and reiterated this recommendation to the company several times in follow-up communication, but the company has not yet recalled the drug.

Since 2016, the FDA has received more than 25 reports indicating confusion between unapproved epinephrine nasal solution and approved epinephrine injectable solution involving similar product labels and containers.

In 2024, the FDA received a report about a patient who received the nasal solution as an injection. The most recent adverse event reported to the FDA involved the BPI Labs’ product and its most recently revised label.

Health care professionals and patients who experience adverse events or quality problems when using medication should report them to the MedWatch Adverse Event Reporting program, the FDA said.