Tarrytown, NY, United States
Regeneron Pharmaceuticals Inc recalls
3 recalls recorded since 2018, most recently on 28 July 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 28 July 2026
- Reason
- Lack of Assurance of Sterility
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0767-2026
- Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regener
Terminated Class II Drugs
- Recall started
- 15 May 2024
- Terminated
- 25 September 2025
- Reason
- Lack of Assurance of Sterility: Complaints of syringe breakage
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0531-2024
- EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Roa
Terminated Class II Drugs
- Recall started
- 23 April 2024
- Terminated
- 25 September 2025
- Reason
- Lack of Assurance of Sterility: Complaints of syringe breakage
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0479-2024
- EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.