FDA Recall D-0097-2026
Bristol-Myers Squibb Company · New Brunswick, NJ
Class II Ongoing 205 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Lack of Assurance of Sterility.
Recall record
- Recall number
D-0097-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-10-21
- Classified by FDA Center
- 2025-10-23
- FDA published
- 2025-10-29
- Recalling firm
- Bristol-Myers Squibb Company
- Firm location
- New Brunswick, NJ
Drug identification
- Brand name(s)
- OPDUALAG
- Generic name(s)
- NIVOLUMAB AND RELATLIMAB-RMBW
- Manufacturer(s)
- E.R. Squibb & Sons, L.L.C.
- NDC(s)
0003-7125- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.