Warning of Confusion Between Nasal and IV Epinephrine

Confusion between approved injectable epinephrine products and unapproved nasal solutions has prompted a warning to healthcare providers and a recall by one manufacturer, according to a January statement from the US Food and Drug Administration (FDA).

The warning applies to unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Florida, and Endo USA, in Malvern, Pennsylvania. These nasal solutions, which should never be injected intravenously, have been confused with approved injectable epinephrine products made by the same companies, according to the statement.

“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 healthcare professionals accidentally injecting the nasal solution instead of the injection product,” according to the FDA.

Since 2016, the FDA has received more than 25 reports of confusion between the nasal solution and injectable products, including one report in 2024 of a patient who was injected with the nasal solution. Citing the potential for accidental injection, Endo USA recalled its unapproved solution. BPI Labs has not yet recalled its product, despite a recommendation from the FDA, according to the statement.

Warning Highlights Need for Communication

“Epinephrine is a critical medication for patients with severe allergic reactions and other life-threatening conditions,” said Alexander Rabin, MD, clinical associate professor of pulmonary and critical care medicine at the University of Michigan, Ann Arbor, in an interview. “Confusing epinephrine product labeling could result in significant harm to patients if a non-sterile product were mistakenly injected into a patient’s bloodstream,” he said.

“I was not aware of this problem prior to the FDA announcement,” said Rabin. “I was surprised to learn that formulations of epinephrine were available with different indications yet overlapping labels,” he added.

The takeaway for clinicians is that the FDA is doing its job by issuing the warning, Rabin told Medscape Medical News. However, in addition to clear labeling, communication among healthcare providers is needed to improve safe epinephrine use, said Rabin. “Open communication between prescribers, pharmacists, and nurses is always important to ensure that we administer the right drug with the right indication to the right patient,” he said.

Healthcare providers and patients should report any adverse events or quality issues through the FDA’s MedWatch Adverse Event Reporting program.

Rabin had no financial conflicts to disclose.