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Regeneron Pharmaceuticals

1 recall on record · Last recall: Jul 28, 2026

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Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious
0
Class II — Moderate
1
Class III — Low Risk
0

Categories

MEDICATION

Recall Timeline

Class IIFDAJul 28, 2026

Regeneron Pharmaceuticals — 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: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01 Lack of Assurance of Sterility

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