FDA-Drug2025-10-29Class II
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
Hazard
Lack of Assurance of Sterility.
Sold states
Nationwide in the USA
Affected count
12,778 total vials
Manufactured in
1 Squibb Dr, New Brunswick, NJ, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief