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.

Docetaxel injection concentrate Recalled by Sanofi-Aventis U.S. LLC Due to Superpotent drug: over-concentrated vials of Docetaxel injection concentrate...

Date: April 27, 2018
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

Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01

Quantity: 19580 vials

Why Was This Recalled?

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.

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.

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