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.

Opdualag (nivolumab and relatlimab-rmbw) injection Recalled by Bristol-Myers Squibb Company Due to Lack of Assurance of Sterility.

Date: October 21, 2025
Company: Bristol-Myers Squibb Company
Status: Ongoing
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 Bristol-Myers Squibb Company directly.

Affected Products

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11

Quantity: 12,778 total vials

Why Was This Recalled?

Lack of Assurance of Sterility.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bristol-Myers Squibb Company

Bristol-Myers Squibb Company has 1 total recall tracked by RecallDetector.

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