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.
What this means for you
Illness, injury, or structural failure has been reported. 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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