Reported Oct 29, 2025 · Ongoing
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
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bristol-Myers Squibb Company · 1 Squibb Dr · New Brunswick, NJ · 08901-1588
Is this the product you have?
- 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
- Lot codes and dates
- Lot033A23B
- Expiry4/30/2026
- Amount recalled
- 12,778 total vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility.
This product could cause temporary or reversible health problems — stop using it.
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