Regeneron Pharmaceuticals recalls
Regeneron Pharmaceuticals has 3 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 26 Aug 2026. 1 is still ongoing. 1 was reported in the last 12 months. The most frequent reason is sterility.
Total recalls3since 2024
Last 12 months1reported
Class I00% of total
Ongoing1latest 26 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why regeneron pharmaceuticals is recalled
Product types
Brands
By year
Ongoing regeneron pharmaceuticals recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Libtayo (cemiplimab-rwlc) Injection, 350 mg/ (50 mg/mL) recalledLibtayo | Regeneron Pharmaceuticals | Sterility | Nationwide |
All regeneron pharmaceuticals recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Libtayo (cemiplimab-rwlc) Injection, 350 mg/ (50 mg/mL) recalledLibtayo | Regeneron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Eylea, (aflibercept) Injection, For Intravitreal injection recalledEylea | Regeneron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Eylea, (aflibercept) Injection, 2 mg of a 40mg/mL solution) recalledEylea | Regeneron Pharmaceuticals | Sterility | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.