Bristol-Myers Squibb Company
FDA Regulatory Profile
Bristol-Myers Squibb Company has 5 FDA recalls (2 Class I), 30 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- D-0097-2026 · Class II · Oct 21, 2025
- Latest inspection
- Apr 28, 2026 · NAI
- Latest 510(k)
- Apr 19, 1996
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 (2 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 30 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
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… | Oct 21, 2025 |
| D-0959-2017 | Class I | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton… | Jun 5, 2017 |
| D-012-2013 | Class I | BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue… | Aug 29, 2012 |
| D-018-2013 | Class II | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For… | Jun 5, 2012 |
| D-019-2013 | Class II | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For… | Jun 5, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Apr 28, 2026 | Lawrenceville, NJ | Drugs | No Action Indicated (NAI) | 1000527006 |
| Jul 8, 2025 | Devens, MA | Drugs | Voluntary Action Indicated (VAI) | 3008455069 |
| Apr 24, 2024 | Princeton, NJ | Drugs | No Action Indicated (NAI) | 3002708128 |
| Feb 2, 2022 | Lawrenceville, NJ | Drugs | No Action Indicated (NAI) | 1000527006 |
| May 24, 2021 | Lawrenceville, NJ | Drugs | No Action Indicated (NAI) | 1000527006 |
| Apr 22, 2020 | Lawrenceville, NJ | Drugs | No Action Indicated (NAI) | 1000527006 |
| Jan 10, 2020 | Devens, MA | Drugs | Voluntary Action Indicated (VAI) | 3008455069 |
| Mar 7, 2019 | Princeton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002708128 |
| Apr 5, 2017 | Devens, MA | Drugs | Voluntary Action Indicated (VAI) | 3008455069 |
| Apr 27, 2016 | Princeton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002708128 |
| Sep 17, 2015 | Wallingford, CT | Drugs | No Action Indicated (NAI) | 1283703 |
| Jun 26, 2015 | Devens, MA | Drugs | No Action Indicated (NAI) | 3008455069 |
| Mar 10, 2015 | Plainsboro, NJ | Drugs | No Action Indicated (NAI) | 3004440557 |
| Oct 16, 2014 | Lawrenceville, NJ | Drugs | No Action Indicated (NAI) | 1000527006 |
| Nov 25, 2013 | Wallingford, CT | Drugs | No Action Indicated (NAI) | 1283703 |
| Nov 22, 2013 | New Brunswick, NJ | Drugs | No Action Indicated (NAI) | 2211101 |
| Jun 20, 2013 | Devens, MA | Drugs | Voluntary Action Indicated (VAI) | 3008455069 |
| May 2, 2013 | Princeton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002708128 |
| Nov 30, 2012 | Wallingford, CT | Drugs | No Action Indicated (NAI) | 1283703 |
| Nov 21, 2012 | Plainsboro, NJ | Drugs | No Action Indicated (NAI) | 3004440557 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1000527006 | Lawrenceville, NJ | 10 | Apr 28, 2026 |
| FEI 3008455069 | Devens, MA | 5 | Jul 8, 2025 |
| FEI 3002708128 | Princeton, NJ | 5 | Apr 24, 2024 |
| FEI 1283703 | Wallingford, CT | 5 | Sep 17, 2015 |
| FEI 3004440557 | Plainsboro, NJ | 2 | Mar 10, 2015 |
| FEI 2211101 | New Brunswick, NJ | 3 | Nov 22, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K960949 | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | Apr 19, 1996 |