WhichRecall
Class IIReported 2025-10-29

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

Recalled by Bristol-Myers Squibb Company

Reason for Recall

Lack of Assurance of Sterility.

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Recall Number
D-0097-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-10-21
Reported
2025-10-29
Distribution
Nationwide in the USA
Code Info
Lot: 033A23B, Expiry: 4/30/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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