Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Sing...
FDA Recall #D-0097-2026 — Class II — October 21, 2025
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
Reason for Recall
Lack of Assurance of Sterility.
Recalling Firm
Bristol-Myers Squibb Company — New Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12,778 total vials
Distribution
Nationwide in the USA
Code Information
Lot: 033A23B, Expiry: 4/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated