Injectable nicardipine recalled due to vial leakage and sterility risk
American Regent is recalling nicardipine hydrochloride injection due to product leakage around vial necks that could compromise sterility. Affected batches were distributed nationwide; healthcare facilities should not use recalled lots.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug with potential loss of sterility assurance. Although no illnesses or injuries have been reported and the hazard remains theoretical, the risk of contamination in an intravenous medication represents serious potential harm to patient populations.
Plain-English summary
American Regent, Inc. is recalling nicardipine hydrochloride injection (25 mg/10 mL vials) nationwide due to product leakage around vial necks that could compromise sterility assurance. The leakage creates a potential risk of infection for patients receiving this intravenous calcium channel blocker.
The recall affects 7,249 cartons distributed nationwide in the United States. Affected lot numbers are 24086N0C0 (expires 7/31/2025), 24076N0C0, 24090N0C0 (expire 8/31/2025), and 25011N0C0 (expires 6/30/2026).
Healthcare facilities and providers should check their inventory against the lot numbers listed and discontinue use of recalled products. Patients should contact their healthcare provider or pharmacist if they have questions about their nicardipine supply or if they received medication from these lots.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injectable / Intravenous
- Hazard
- product-leakage
- sterility-compromise
- contamination-risk
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 (8)
- Lots
- expiry: Lot 24086N0C0
- 7/31/2025
- Lot 24076N0C0
- Lot 24090N0C0
- 8/31/2025
- Lot 25011N0C0
- 6/30/2026
Distribution
Distributed nationwide across the United States.
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