Recalls / Class II
Class IID-0097-2026
Product
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
- Brand name
- Opdualag
- Generic name
- Nivolumab And Relatlimab-rmbw
- Active ingredients
- Nivolumab, Relatlimab
- Route
- Intravenous
- NDC
- 0003-7125
- FDA application
- BLA761234
- Affected lot / code info
- Lot: 033A23B, Expiry: 4/30/2026
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- Bristol-Myers Squibb Company
- Manufacturer
- E.R. Squibb & Sons, L.L.C.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Squibb Dr, New Brunswick, New Jersey 08901-1588
Distribution
- Quantity
- 12,778 total vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-10-21
- FDA classified
- 2025-10-23
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0097-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.