Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Epinephrine Injection Recalled by Luitpold Pharmaceuticals, Inc. Due to Presence of Particulate Matter

Date: April 24, 2012
Company: Luitpold Pharmaceuticals, Inc.
Status: Terminated
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 Luitpold Pharmaceuticals, Inc. directly.

Affected Products

Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25

Quantity: 63,750 ampules

Why Was This Recalled?

Presence of Particulate Matter

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Luitpold Pharmaceuticals, Inc.

Luitpold Pharmaceuticals, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

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