Regeneron Pharmaceuticals Inc

FDA Regulatory Profile

Regeneron Pharmaceuticals Inc appears in FDA public data with 3 recalls, 0 510(k) clearances, 23 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0767-2026, Class II) was initiated on July 28, 2026.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
23
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0767-2026Class IILibtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After DilutionJuly 28, 2026
D-0531-2024Class IIEYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), SinMay 15, 2024
D-0479-2024Class IIEYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe,April 23, 2024