CLASS II ONGOING Drug recall · Reported 26 Aug 2026 · FDA Enforcement Report
Libtayo (cemiplimab-rwlc) Injection, 350 mg/ (50 mg/mL) recalled
Regeneron Pharmaceuticals is recalling Libtayo (cemiplimab-rwlc) Injection, 350 mg/ (50 mg/mL), For Intravenous Infusion After, distributed nationwide in the US. The recall was initiated on 28 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0767-2026
- FDA event ID
- 99523
- Recalling firm
- Regeneron Pharmaceuticals, Tarrytown, NY
- Brand
- Libtayo
- Manufacturer
- Regeneron Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Jul 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Jul 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +17 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: 8494000002, Exp 7/31/28
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Regeneron Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Eylea, (aflibercept) Injection, For Intravitreal injection recalledEylea | Regeneron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Eylea, (aflibercept) Injection, 2 mg of a 40mg/mL solution) recalledEylea | Regeneron Pharmaceuticals | Sterility | Nationwide |