Mckesson
FDA Regulatory Profile
Mckesson appears in FDA public data with 4 recalls — including 1 Class I (most serious) —, 5 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0714-2026, Class II) was initiated on June 10, 2026. Its most recent 510(k) clearance was granted on August 2, 1977.
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 5
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0714-2026 | Class II | Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusio | June 10, 2026 |
| D-0353-2026 | Class I | UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu | January 16, 2026 |
| D-0213-2025 | Class II | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx o | January 17, 2025 |
| D-0005-2015 | Class II | Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured fo | September 12, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K771175 | RESUSCITATOR, MS30 | August 2, 1977 |
| K761196 | NITROUS OXIDE SCAVENGING MASK | December 13, 1976 |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | December 9, 1976 |
| K761194 | HLR QUICK-FIT HEART-LUNG RESUSCITATOR | December 9, 1976 |
| K760017 | CONSIOUS SEDATION (ANALOR P-76) | July 20, 1976 |