FDAHealthOctober 21, 2025
Bristol-Myers Squibb Company — 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
⚠️ Lack of Assurance of Sterility.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 21, 2025
Nationwide in the USA
What's affected?
- 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
- Brand
- OPDUALAG
- Lot code
- 033A23B
Additional details
Lot: 033A23B, Expiry: 4/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12,778 total vials.
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