Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Enoxaparin Sodium Recalled by Sanofi-Aventis U.S. LLC Due to Labeling: Label Error on Declared Strength. A single...

Date: December 5, 2017
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

Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10

Quantity: 11,474 cartons of 10 syringes per carton

Why Was This Recalled?

Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL

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