Bristol-Myers Squibb Company recalls Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only,
Recalled October 29, 2025 · FDA recall D-0097-2026 · Bristol-Myers Squibb
Hazard
Lack of Assurance of Sterility. · FDA Class II
Units
12,778 total vials
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility.
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
Manufacturer(s)
Bristol-Myers Squibb Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →