Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Adrenalin Chloride Solution (Epinephrine Nasal Solution Recalled by ENDO USA, Inc. Due to Labeling: Not Elsewhere Classified: misleading label similar in...

Date: December 20, 2024
Company: ENDO USA, Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ENDO USA, Inc. directly.

Affected Products

Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01

Quantity: 44,397 amber glass vials

Why Was This Recalled?

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ENDO USA, Inc.

ENDO USA, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report