FDAFDA · Food and drugs·Recall number D-0097-2026
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
Published October 29, 2025 · Recall initiated: October 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OPDUALAG
- Manufacturer
- Bristol-Myers Squibb Company
- Distributor
- Nationwide in the USA
- Lot
- Lot: 033A23B, Expiry: 4/30/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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