Medications & Supplements/Prescription Drugs

Adrenalin Chloride Solution Recalled for Misleading Labeling

Agency Publication Date: February 5, 2025

Summary

ENDO USA, Inc. is recalling 44,397 vials of Adrenalin Chloride Solution (epinephrine nasal solution). The recall was initiated because the product's labeling is misleading and looks similar to the FDA-approved drug Adrenalin (epinephrine injection, USP). This similarity could lead to medication errors where the nasal solution is accidentally injected into a patient.

Risk

If this nasal solution is incorrectly administered as an injection due to label confusion, it could result in serious medical errors or improper treatment. The risk is classified as critical due to the potential for confusion with a life-saving injectable medication.

What You Should Do

This recall affects all unexpired lots of Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL amber glass vials.
Identify affected products by checking for NDC 42023-103-01 on the label. The product was distributed by Par Pharmaceutical.
If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact ENDO USA, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL)

Variants: 30mg/30mL (1mg/mL), 30 mL vials, Amber glass vials

Lot Numbers:

All lots within expiry

NDC:

42023-103-01

Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96013

Status: Active

Manufacturer: ENDO USA, Inc.

Sold By: Par Pharmaceutical

Manufactured In: United States

Units Affected: 44,397 amber glass vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects all unexpired lots of Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL amber glass vials.

Identify affected products by checking for NDC 42023-103-01 on the label. The product was distributed by Par Pharmaceutical.

If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact ENDO USA, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.