FDA recall D-0097-2026

Bristol-Myers Squibb Company · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-10-21
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: New Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2026