Nicardipine Hydrochloride Injection, Solution
FDA Recall NDC 0517-0735
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nicardipine Hydrochloride (NDC 0517-0735). A significant event, classified as Class II, was initiated on Apr 18, 2025 by American Regent, 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
7,249 (cartons of 10 x 10 mL 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, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Batch or Lot Expiration Information
Lot# Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026
Affected Packages Involved in this Recall
0517-0735-01Product
0517-0735-10Product
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.
