Class I โ€” Serious Health Hazard

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

Auvi-Q (epinephrine injection Recalled by Sanofi-Aventis U.S. LLC Due to Defective Delivery System; potential to have inaccurate dosage...

Date: October 28, 2015
Company: Sanofi-Aventis U.S. LLC
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 Sanofi-Aventis U.S. LLC directly.

Affected Products

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company

Quantity: 383,900 prefilled syringes

Why Was This Recalled?

Defective Delivery System; potential to have inaccurate dosage delivery

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sanofi-Aventis U.S. LLC

Sanofi-Aventis U.S. LLC has 22 total recalls tracked by RecallDetector.

Related Recalls

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