Nicardipine Hydrochloride Injection Recalled for Potential Sterility Loss
American Regent, Inc. is recalling certain lots of Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects 7,249 cartons distributed nationwide.
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 FDA classified this as Class II. Sterility loss in an intravenous injection product presents significant risk of serious infection and adverse health consequences, meeting the Severe threshold for FDA Class II recalls with potential for serious injury.
Plain-English summary
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL) in 10 mL single-dose vials due to potential product leakage around the vial neck. This defect could result in a lack of sterility assurance.
The affected product includes Lot 24086N0C0 (expiry 7/31/2025), Lot 24076N0C0 (expiry 8/31/2025), Lot 24090N0C0 (expiry 8/31/2025), and Lot 25011N0C0 (expiry 6/30/2026). A total of 7,249 cartons, each containing 10 vials, have been distributed nationwide in the USA.
Nicardipine Hydrochloride Injection is an intravenous prescription drug used for cardiovascular indications. Healthcare providers should discontinue use of affected lots and check their inventory immediately. Patients should contact their healthcare provider with any questions about their treatment.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injectable / Intravenous
- Hazard
- sterility-loss
- product-leakage
- 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.
Related recalls
Same brand · NICARDIPINE HYDROCHLORIDE
- SevereNicardipine Hydrochloride Injection Recalled for Potential Sterility Issues
FDA (Drugs) · 2025-05-07
- ModerateNicardipine Hydrochloride Injection Recalled for Sterility Assurance Concerns
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- HighNicardipine Hydrochloride Injection Recalled for Out-of-Specification Organic Impurities
FDA (Drugs) · 2024-03-27
- HighNicardipine Hydrochloride Injection Recalled Due to Out-of-Specification Organic Impurities
FDA (Drugs) · 2024-03-27
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