Regeneron Pharmaceuticals, Inc.
NDC labeler code: 61755
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- AfliberceptZaltrap, Pavblu, Eylea Hd · 3 products
- AlirocumabPraluent · 2 products
- Atoltivimab, maftivimab, and odesivimab-ebgnInmazeb · 2 products
- Lunsotogene parvec-cwhaOtarmeni · 1 product
- Cemiplimab-rwlcLibtayo · 1 product
- Garetosmab-grtsPasatru · 1 product
- PozelimabVeopoz · 1 product
FDA applications for these products
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 19, 2026 | BLA761508 | Garetosmab-grts PASATRU | Regeneron Pharmaceuticals, Inc |
| August 18, 2023 | BLA761339 | Pozelimab VEOPOZ | Regeneron Pharmaceuticals |
| August 18, 2023 | BLA761355 | Aflibercept EYLEA HD | Regeneron Pharmaceuticals |
| October 14, 2020 | BLA761169 | Atoltivimab, maftivimab, and odesivimab-ebgn INMAZEB | Regeneron Pharmaceuticals |
| September 28, 2018 | BLA761097 | Cemiplimab-rwlc LIBTAYO | Regeneron Pharmaceuticals |
| July 24, 2015 | BLA125559 | Alirocumab PRALUENT | Regeneron Pharmaceuticals |
| November 18, 2011 | BLA125387 | Aflibercept EYLEA | Regeneron Pharmaceuticals |
| — | BLA125874 | Lunsotogene parvec-cwha | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
July 28, 2026 · Class II · Ongoing · D-0767-2026 · Cemiplimab-rwlc
Lack of Assurance of Sterility
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
2024
-
May 15, 2024 · Class II · Terminated · D-0531-2024 · Aflibercept
Lack of Assurance of Sterility: Complaints of syringe breakage
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
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April 23, 2024 · Class II · Terminated · D-0479-2024 · Aflibercept
Lack of Assurance of Sterility: Complaints of syringe breakage
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-
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026