Bristol-myers Squibb Company
FDA Regulatory Profile
Bristol-myers Squibb Company appears in FDA public data with 5 recalls — including 2 Class I (most serious) —, 1 510(k) clearance, 18 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0097-2026, Class II) was initiated on October 21, 2025. Its most recent 510(k) clearance was granted on April 19, 1996.
Summary
- Total Recalls
- 5 (2 Class I)
- 510(k) Clearances
- 1
- Inspections
- 18
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0097-2026 | Class II | Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single | October 21, 2025 |
| D-0959-2017 | Class I | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, | June 5, 2017 |
| D-012-2013 | Class I | BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Labor | August 29, 2012 |
| D-019-2013 | Class II | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sal | June 5, 2012 |
| D-018-2013 | Class II | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sal | June 5, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K960949 | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | April 19, 1996 |