RecallDepth
Class II 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, Princeton, NJ 08543, NDC 0003-7125-11

Company
Bristol-Myers Squibb Company
Recall Initiated
October 21, 2025
Posted
October 29, 2025
Recall Number
D-0097-2026
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
12,778 total vials
Firm Location
New Brunswick, NJ, United States

Reason for Recall

Lack of Assurance of Sterility.

Distribution

Nationwide in the USA

Lot / Code Info

Lot: 033A23B, Expiry: 4/30/2026

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