Class IIDrug
Libtayo recall
Summary
Regeneron Pharmaceuticals Inc is recalling Libtayo (cemiplimab-rwlc) Injection (drug). According to the FDA report, the reason is: Lack of Assurance of Sterility. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Reason
- Lack of Assurance of Sterility
- Lot / code info
- Lot: 8494000002, Exp 7/31/28
- Quantity
- 21,353 vials
- Distribution
- USA Nationwide
- Recalling company
- Regeneron Pharmaceuticals Inc, Tarrytown, NY United States
- Recall started
- July 28, 2026
- FDA report date
- August 26, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0767-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Regeneron Pharmaceuticals Inc) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.