Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 8494000002, Exp 7/31/28
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0767-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 28, 2026
- FDA report date
- Aug 26, 2026
- Quantity
- 21,353 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Regeneron Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0767-2026, exactly as published.
Show all FDA fields
- City
- Tarrytown
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 99523
- Address
- 777 Old Saw Mill River Rd
- Code information
- Lot: 8494000002, Exp 7/31/28
- Postal code
- 10591-6717
- Report date
- Aug 26, 2026
- Product type
- Drugs
- Recall number
- D-0767-2026
- Classification
- Class II
- Recalling firm
- Regeneron Pharmaceuticals Inc
- Product quantity
- 21,353 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 28, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2026