EPINEPHrine Nasal Solution, USP Recalled for Lack of Approval, Misbranding

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Key Takeaways

EPINEPHrine nasal solution recall addresses unapproved status and misleading labeling, risking medication errors and patient safety.
The recall affects specific lots distributed nationwide, excluding FDA-approved Adrenalin injection, which remains safe.
Healthcare providers must stop using the recalled product, verify labeling, and avoid intravenous administration of non-sterile products.
The manufacturer is facilitating returns, with no adverse events reported in the past five years.

The nasal spray label resembles that of the FDA-approved epinephrine injection, leading to potential dosing errors.

The FDA has issued a recall of EPINEPHrine nasal solution, USP (Adrenalin Chloride Solution; Endo) 30mg/30mL (1mg/mL) 30 mL vials. This recall does not affect the FDA-approved Adrenalin (epinephrine injection, USP; 1mg/mL) 30mL vial, which remains safe for use.¹

Pharmacist holding nasal spray bottle | Image Credit: © I Viewfinder - stock.adobe.com

EPINEPHrine nasal solution is an emergency treatment of severe allergic reactions such as anaphylaxis. The recall addresses concerns around the product’s unapproved status and misbranding, as it predates the 1938 Federal Food, Drug & Cosmetic Act and was never submitted for FDA approval. As such, its safety and efficacy have not been established. As of 2024, the only approved nasal solution for anaphylaxis on the market is epinephrine nasal spray (neffy; ARS Pharmaceuticals Operations, Inc).^2-4

The FDA determined the EPINEPHrine nasal solution, USP’s labeling to be misleading, resembling the FDA-approved epinephrine injection, USP (Adrenalin; Endo) (1mg/mL) 30mL vial. Each product serves different purposes, creating a risk of medication errors due to their similar appearance. The non-sterile nasal solution, designed for topical use as a vasoconstrictor, poses a risk of infection and incorrect dosing when used intravenously. This could lead to delayed or inadequate treatment of critical conditions such as anaphylaxis, hemodynamic instability, and cardiac arrest. Patients receiving the incorrect dose of epinephrine during emergencies may face life-threatening outcomes, including death.¹

The recall applies to the following lots for topical application:

82809 (Expiry: 03/2026)
79637 (Expiry: 11/2025)
77776 (Expiry: 07/2025)
74716 (Expiry: 05/2025)
1835 (Expiry: 01/2025)
(Expiry: 01/2025)

The product, distributed nationwide from October 10, 2023, through December 11, 2024, is packaged in individually packed cartons under NDC #42023-103-01. The label includes the language “Nasal Solution USP” and “For Topical Application.”¹

This recall does not affect the FDA-approved Adrenalin (epinephrine injection, USP) (1mg/mL) 30mL vial, which remains safe for use. The company has reported no adverse events related to the recalled product in the past 5 years.¹

The manufacturer is working to facilitate the return of affected inventory. Health care providers and wholesale distributors are advised to immediately stop using and distributing the recalled product. Written notifications are being sent to all direct customer accounts to ensure awareness and compliance. The company urges pharmacists and health care professionals to carefully verify product labeling and avoid administering unapproved or non-sterile products intravenously.¹

The recall highlights the critical importance of clear and accurate labeling to prevent potential medication errors. It also underscores the necessity for health care providers to remain vigilant in verifying product information, especially in emergency settings. For more information about the recall or assistance with returning the product, customers should contact Endo or Inmar, Inc. directly. Healthcare professionals are encouraged to report any adverse events or quality issues to the FDA’s MedWatch program.¹

REFERENCES

1. Endo USA, Inc. issues voluntary, nationwide recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) due to the potential for administration errors. FDA. December 20, 2024. Accessed December 23, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal?utm_medium=email&utm_source=govdelivery

2. Epinephrine (nasal route). Mayo Clinic. October 1, 2024. Accessed December 23, 2024. https://www.mayoclinic.org/drugs-supplements/epinephrine-nasal-route/description/drg-20572412

3. FDA approves first nasal spray for treatment of anaphylaxis. FDA. August 9, 2024. Accessed December 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis

4. FDA approves first nasal spray for anaphylaxis. Pharmacy Times. August 9, 2024. Accessed December 23, 2024. https://www.pharmacytimes.com/view/fda-approves-first-nasal-spray-for-anaphylaxis