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
Reported: October 29, 2025 Initiated: October 21, 2025 #D-0097-2026
Product Description
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
Reason for Recall
Lack of Assurance of Sterility.
Details
- Recalling Firm
- Bristol-Myers Squibb Company
- Units Affected
- 12,778 total vials
- Distribution
- Nationwide in the USA
- Location
- New Brunswick, NJ
Frequently Asked Questions
What product 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. Recalled by Bristol-Myers Squibb Company. Units affected: 12,778 total vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 29, 2025. Severity: Moderate. Recall number: D-0097-2026.
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