D-0097-2026 Class II Ongoing
FDA drug recall D-0097-2026 was initiated by Bristol-Myers Squibb Company on Oct 21, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility. The recall status is ongoing. Affected quantity: 12,778 total vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 29, 2025
- Initiation Date
- Oct 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,778 total vials
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
Reason for Recall
Lack of Assurance of Sterility.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 033A23B, Expiry: 4/30/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0097-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026