[1/16/2025] The FDA is warning health care professionals not to use unapproved epinephrine nasal sprays manufactured by BPI Labs LLC, Largo, Florida, and Endo USA, Malvern, Pennsylvania. Medical professionals confuse these products with FDA-approved intravenous epinephrine injection products. use. BPI Labs and Endo USA nasal spray products should never be injected intravenously.

Nasal solutions and injections have similar packaging and containers and are manufactured by the same company. Because the bottles and packaging labels for nasal spray products and sterile injectables are similar, it is difficult to distinguish between the two, and there is a possibility that healthcare workers may mistakenly inject the nasal spray instead of the nasal spray product. There is.

Unlike injectable drugs, nasal sprays do not need to be sterile. Injecting nonsterile drugs can cause infections, which can be life-threatening for certain patients.

Medical professionals use both products in hospitals and medical settings.

Figure 1: Left image: BPI Labs’ FDA-approved epinephrine injection (bottle with blue cap)
Image on the right: BPI Labs Unapproved Epinephrine Chloride Nasal Solution (Bottle with Red Cap)
Photos submitted to FDA through adverse event reports

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Figure 2: Left image: BPI Labs recently updated their labels and packaging. A new, unapproved epinephrine chloride nasal solution. It comes with a red bottle lid and a maroon label in a maroon box.
Image on the right: BPI Labs’ FDA-approved epinephrine injection. The bottle lid is blue and the bottle and packaging have purple highlights.
Photo provided to FDA by BPI Labs

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Figure 3: Left image: Endo USA’s unapproved chloride epinephrine (epinephrine) nasal solution. It says Par Pharmaceuticals and has a blue cap on the bottle.
Image on the right: Endo USA’s FDA-approved adrenaline (epinephrine) injection. It says Par Pharmaceuticals and has a red cap on the bottle.
Photos submitted to FDA through adverse event reports

Endo USA announced on December 20, 2024, that an unapproved chloride adrenaline solution (Epinephrine Nasal Solution, USP) could be used by healthcare professionals to accidentally inject a nasal solution instead of an injectable product. was recalled voluntarily.

The FDA recommended that BPI Labs recall its unapproved epinephrine nasal spray on December 12, 2024. The FDA followed up with the company several times and reiterated this recommendation. The most recent adverse event report received by the FDA included a product with a recently revised label from BPI Labs (Figure 2, left image). The company has not taken any action to remove unapproved drugs from the market.

Since 2016, FDA has received more than 25 reports of confusion between unapproved epinephrine nasal sprays and approved epinephrine injections, including similarities in product labels and containers. As recently as 2024, authorities received reports of patients who were given nasal drops as injections.

FDA encourages health care professionals and patients to report adverse events or quality problems they experience with their medicines to FDA’s MedWatch Adverse Event Reporting Program.

  • Complete and submit your report online;or
  • Download the form, fill it out, and fax it to 1-800-FDA-0178.