drugs MODERATE Updated 2026-08-26

Regeneron Pharmaceuticals Inc recalls Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL),

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Recalled Product

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

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Hazard / Issue

Lack of Assurance of Sterility

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 8494000002, Exp 7/31/28

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall