Recalling firm
Bristol-Myers Squibb Company
Product type
Drug
Status
Ongoing
Report date
2025-10-29
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
12,778 total vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility.
Product description
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
Code / lot info
Lot: 033A23B, Expiry: 4/30/2026
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.