Brandtree

Regeneron's product recalls

3 official recall notices between May 2024 and Aug 2026 were matched to Regeneron and brands it owned at the time, including Eylea and Libtayo.

Each notice concerns the specific products, sizes and lot codes it names. A recall does not mean that other Regeneron products are affected, and a count of notices is not a measure of safety: one incident can produce a notice for every pack size.

Covers only notices from the U.S. Food and Drug Administration enforcement reports (openFDA), USDA Food Safety and Inspection Service recalls, UK Food Standards Agency food alerts and U.S. Consumer Product Safety Commission recalls that could be matched to Regeneron: the recalling firm must be Regeneron, a parent or a subsidiary, and for a brand the brand name must appear in the product description. Method.

2026 (1)

DateProductBrandRecalling firmReason givenSource
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron… Libtayo Regeneron Pharmaceuticals Inc Lack of Assurance of Sterility Class II FDA

2024 (2)

DateProductBrandRecalling firmReason givenSource
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured… Eylea Regeneron Pharmaceuticals Inc Lack of Assurance of Sterility: Complaints of syringe breakage Class II FDA
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals,… Eylea Regeneron Pharmaceuticals Inc Lack of Assurance of Sterility: Complaints of syringe breakage Class II FDA

Product descriptions and reasons are shortened from the regulators' own text; the linked notice is the authoritative record. See all matched recalls, or report a wrong match through the corrections page.