Nicardipine Hydrochloride Injection, Solution
FDA Recall NDC 72572-470
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nicardipine Hydrochloride (NDC 72572-470). A significant event, classified as Class II, was initiated on Apr 18, 2025 by Civica, Inc.. The reported reason for this action was: "Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Apr 18, 2025
May 07, 2025
29,777 (cartons of 10 x 10mL vials)
Recall Profile & Regulatory Data
Event ID
96695
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
American Regent, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.
Batch or Lot Expiration Information
Lot# Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026
Affected Packages Involved in this Recall
72572-470-01Product
72572-470-10Product
Class II Terminated
Lack of Assurance of Sterility.
May 14, 2024
May 29, 2024
4,136 cartons (10 vials in each carton)
Recall Profile & Regulatory Data
Event ID
94621
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Regent, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
UT only
Termination Date
Dec 23, 2025
Product Description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
Batch or Lot Expiration Information
Lot# : 23087N0C0, Exp. Date 11/2024
Affected Packages Involved in this Recall
72572-470-01Product
72572-470-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
