Regeneron Pharmaceuticals Inc FDA Recalls

3 recalls on file across drugs, 0 of them Class I and 1 still open. Matched by name to REGN.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Class IIJul 28, 2026Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Jul 28, 2026
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Class IIMay 15, 2024Lack of Assurance of Sterility: Complaints of syringe breaka	Lack of Assurance of Sterility: Complaints of syringe breakage	Class IIDrugs	May 15, 2024
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, ManufacturClass IIApr 23, 2024Lack of Assurance of Sterility: Complaints of syringe breaka	Lack of Assurance of Sterility: Complaints of syringe breakage	Class IIDrugs	Apr 23, 2024