Nicardipine Hydrochloride

Nicardipine Hydrochloride recalls: 6 FDA reports

Recalls involving Nicardipine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.

6Reports
0Class I
4Ongoing
2025-05-07Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II5
Class III1

By year reported

YearReports
20131
20243
20252
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: C

D-0398-2025  ·  Class II  ·  reported 2025-05-07  ·  Ongoing

Why it was recalled
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Product
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.
Where it went
Nationwide in the USA
How much
29,777 (cartons of 10 x 10mL vials)

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American R

D-0399-2025  ·  Class II  ·  reported 2025-05-07  ·  Ongoing

Why it was recalled
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Product
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]
Where it went
Nationwide in the USA
How much
7,249 (cartons of 10 x 10 mL vials)

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For

D-0503-2024  ·  Class II  ·  reported 2024-05-29  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility.
Product
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
Where it went
UT only
How much
4,136 cartons (10 vials in each carton)

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LL

D-0391-2024  ·  Class II  ·  reported 2024-03-27  ·  Ongoing

Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Product
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
Where it went
Nationwide within the United States
How much
43,920 vials

Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMe

D-0390-2024  ·  Class II  ·  reported 2024-03-27  ·  Ongoing

Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Product
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Where it went
Nationwide within the United States
How much
335,940 vials

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Ph

D-691-2013  ·  Class III  ·  reported 2013-07-17  ·  Terminated

Why it was recalled
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Product
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
Where it went
Nationwide
How much
Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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