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.

Eloxatin (OXALIplatin injection) 5 mg/mL injection Recalled by sanofi-aventis US, Inc. Due to CGMP Deviations: Eloxatin was manufactured by Ben Venue...

Date: February 6, 2012
Company: sanofi-aventis US, 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 sanofi-aventis US, Inc. directly.

Affected Products

Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20

Quantity: 387,738 vials

Why Was This Recalled?

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About sanofi-aventis US, Inc.

sanofi-aventis US, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

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