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

FDA recall notice · announced October 29, 2025 · Bristol-myers Squibb

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 033A23B, Expiry: 4/30/2026
Quantity: 12,778 total vials
Status: Ongoing
Products in this recall event:
- 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 (D-0097-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.