Recall Register

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Regeneron Pharmaceuticals Inc

FDA recalling firm · 3 enforcement events · 3 product records · 2024–2026 · NY

Regeneron Pharmaceuticals Inc has 3 FDA enforcement events on this register (3 product records) between 2024 and 2026: 3 drug; the busiest year was 2024 with 2.

0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
28 Jul 2026Libtayo (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: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01DrugClass II1Ongoing
15 May 2024EYLEA, (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 Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54DrugClass II1Terminated
23 Apr 2024EYLEA, (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 61755-005-01DrugClass II1Terminated

By type and class

Drug3
Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

24
25
26
Enforcement events for Regeneron Pharmaceuticals Inc by year initiated.

Questions and answers

How many FDA recalls has Regeneron Pharmaceuticals Inc had?

3 enforcement events (3 product records) on this register, 2024–2026: 3 drug.

Are any Regeneron Pharmaceuticals Inc recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Regeneron Pharmaceuticals Inc recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.