Regeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
Regeneron is recalling 21,353 vials of Libtayo (cemiplimab-rwlc) injection nationwide due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an intravenous drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Regeneron Pharmaceuticals Inc. is recalling 21,353 vials of Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL, for intravenous infusion. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by Lot 8494000002 with an expiration date of 7/31/28.
The recall covers distribution across the USA. Libtayo is a prescription-only medication manufactured and marketed by Regeneron Pharmaceuticals, Inc. in Tarrytown, NY.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or Regeneron for further instructions. Do not administer the recalled product.
The recalled product
- Product
- LIBTAYO (CEMIPLIMAB-RWLC)
- Brand
- LIBTAYO
- Manufacturer
- Regeneron Pharmaceuticals Inc
- Category
- Drug — Prescription Injection
- Affected units
- 21,353
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 8494000002
- Exp 7/31/28
Distribution
Distributed nationwide across the United States.
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