Nicardipine Hydrochloride Injection Recalled for Sterility Assurance Concerns
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection (25 mg/10 mL) in one lot due to lack of assurance of sterility. The recall affects approximately 4,136 cartons distributed in Utah.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall without reported illnesses or hospitalizations; precautionary recall due to sterility assurance concerns without confirmed contamination, fitting the 'voluntary precautionary recalls' criterion at severity score 2.
Plain-English summary
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL) due to lack of assurance of sterility. The affected product is lot number 23087N0C0 with expiration date 11/2024 (NDC 72572-470-10). Approximately 4,136 cartons, each containing 10 single-dose vials, were distributed in Utah.
The recalled product was manufactured by American Regent, Inc., New Albany, OH for Civica, Inc., Lehi, UT. Nicardipine Hydrochloride Injection is an intravenous medication prescribed for blood pressure management.
Persons who have received this medication should contact their healthcare provider with questions about their current medication. Healthcare facilities should identify and quarantine remaining product with lot number 23087N0C0.
This recall was initiated by American Regent, Inc. at the request of the FDA. For more information about this recall, contact the FDA Drug Safety office or the recalling manufacturer.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Cardiovascular Injection
- Hazard
- contamination
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 #: 23087N0C0
- Exp. Date 11/2024
Distribution
Distributed in 1 state:
- UT
Related recalls
Same brand · NICARDIPINE HYDROCHLORIDE
- HighInjectable nicardipine recalled due to vial leakage and sterility risk
FDA (Drugs) · 2025-05-07
- HighInjectable Drug Recalled for Potential Sterility Issues Due to Product Leakage
FDA (Drugs) · 2025-05-07
- 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
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27