US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Oct 21, 2025 (11 months ago)

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility.

What was recalled

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

Recalling firm
Bristol-Myers Squibb Company
NDC code
0003-7125-11
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0097-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.