Nivolumab and Relatlimab Recall: Opdualag injection
Announced 2025-10-29 · FDA
The FDA is recalling Opdualag injection (nivolumab and relatlimab) due to lack of assurance of sterility. About 12,778 vials distributed nationwide in the United States are affected. The affected lot is Lot 033A23B with expiry 4/30/2026.
| Brand | Bristol-Myers Squibb Company |
|---|---|
| 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 | Lack of Assurance of Sterility. |
| Severity | moderate |
| Units affected | 12778 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Lot: 033A23B, Expiry: 4/30/2026 |
WHAT YOU SHOULD DO
- Do not use Opdualag injections from Lot 033A23B or any vial until you are advised by your healthcare provider.
- If you have a recalled vial, contact your healthcare provider or the pharmacy that dispensed it for guidance on replacement or return.
- Keep the product packaging with the lot and expiry information for reference and reporting purposes.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.