Opdualag injection recalled over sterility concerns
- Recall date
- October 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bristol-Myers Squibb Company recalls Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only,…
- Recall number
- D-0097-2026
- FDA classification
- Class II
- Brand / firm
- Bristol-Myers Squibb Company
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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
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