Nationwide Recall: Unapproved EPINEPHrine Nasal Solution Raises Safety Concerns

Key Insights

• The FDA has initiated a recall of EPINEPHrine nasal solution, USP by Endo due to lack of FDA approval and misbranding concerns, as the product predates the 1938 Federal Food, Drug & Cosmetic Act.
• The recall addresses potential safety risks from product confusion with FDA-approved Adrenalin injection, with similar labeling potentially leading to medication errors and life-threatening outcomes in emergency situations.
• Six specific lots distributed nationwide between October 2023 and December 2024 are affected, while the FDA-approved Adrenalin injection remains safe for continued use.

The U.S. Food and Drug Administration has announced a nationwide recall of EPINEPHrine nasal solution, USP (Adrenalin Chloride Solution) 30mg/30mL manufactured by Endo, marking a significant safety intervention in the emergency medicine sector. The recall specifically targets the unapproved nasal formulation while leaving the FDA-approved Adrenalin injection product unaffected.

Safety Concerns and Regulatory Status

The recalled product, which predates the 1938 Federal Food, Drug & Cosmetic Act, has never received FDA approval, raising fundamental questions about its safety and efficacy. The timing is particularly notable as it follows the 2024 approval of neffy (epinephrine nasal spray) by ARS Pharmaceuticals Operations, Inc., currently the only FDA-approved nasal solution for anaphylaxis treatment.

Risk of Medication Errors

A primary concern driving the recall is the product's misleading labeling, which bears a close resemblance to the FDA-approved epinephrine injection, USP (Adrenalin). This similarity creates a significant risk of medication errors, particularly in emergency situations. The non-sterile nasal solution, intended for topical use as a vasoconstrictor, could lead to serious complications if administered intravenously, including:

• Potential infections from non-sterile formulation
• Incorrect dosing in emergency situations
• Delayed treatment of critical conditions
• Life-threatening outcomes in cases of anaphylaxis or cardiac emergencies

Affected Products and Distribution

The recall encompasses six specific lots distributed nationwide from October 10, 2023, through December 11, 2024:

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

The product is packaged in individual cartons with NDC #42023-103-01, labeled as "Nasal Solution USP" and "For Topical Application."

Immediate Actions Required

Healthcare providers and distributors are instructed to immediately cease using and distributing the recalled product. Endo has initiated direct communication with customer accounts and is facilitating the return of affected inventory. Despite the recall's scope, the company reports no adverse events related to the product in the past five years.

Market Impact and Alternative Options

The recall highlights the evolving landscape of anaphylaxis treatment options, with neffy emerging as the only FDA-approved nasal spray alternative. Healthcare professionals are reminded that the FDA-approved Adrenalin injection remains available and safe for continued use, providing a reliable option for emergency treatment.