Opdualag — Class II drug recall D-0097-2026
Ongoing recall by Bristol-Myers Squibb Company, reported 2025-10-29, distributed nationwide. Lack of Assurance of Sterility.
| Recall number | D-0097-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bristol-Myers Squibb Company, New Brunswick, NJ, United States |
| Recall initiated | 2025-10-21 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 12,778 vials |
| Reason classes | sterility |
| NDC | 00003-7125, 00003-7125-11 |
| Lot numbers | 033A23B |
| Expiration dates | 2026-04-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0097-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.