Bristol-Myers Squibb Company: Drug Recall
Recall #D-0097-2026 · 10/21/2025
Class II: Risk
Recall Details
- Recall Number
- D-0097-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Bristol-Myers Squibb Company
- Status
- Ongoing
- Date Initiated
- 10/21/2025
- Location
- New Brunswick, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,778 total vials
Reason for Recall
Lack of Assurance of Sterility.
Product Description
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
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.