FDA Drug recall D-0097-2026
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squib…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squib… by Bristol Myers Squibb, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0097-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-21 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bristol Myers Squibb |
| Distribution | US |
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.
Identifiers
| ndc | 0003-7125-11 |
|---|---|
| code_info | Lot: 033A23B, Expiry: 4/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Bristol Myers Squibb
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FDA Drug · Class I · 2017-07-19 · Bristol Myers Squibb - Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg…
FDA Drug · Class II · 2012-10-31 · Bristol Myers Squibb - Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, R…
FDA Drug · Class II · 2012-10-31 · Bristol Myers Squibb - BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc
FDA Drug · Class I · 2012-10-31 · Bristol Myers Squibb
All Bristol Myers Squibb recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0097-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.