Class II

Drug Recall: 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

Bristol-Myers Squibb Company · October 21, 2025

Reason for Recall

Lack of Assurance of Sterility.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

12,778 total vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0097-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.