FDA Drugs recall ·
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL)… recall
- Recall number
- D-0767-2026
- Date
- (initiated July 28, 2026)
- Company / brand
- Regeneron Pharmaceuticals Inc
777 Old Saw Mill River Rd, Tarrytown, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 21,353 vials
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 8494000002, Exp 7/31/28
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0767-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.