Nicardipine recalls

The FDA has published 13 recalls involving Nicardipine since 2013. The latest was reported on 9 Sep 2026. Most were for sterility. American Regent has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls13since 2013

Last 12 months2reported

Class I00% of total

Ongoing6latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 2May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 1Aug 1 0

Severity split

Class I 0 0%Class II 11 85%Class III 2 15%

Why nicardipine is recalled

Companies

Brands

Nicardipine Hydrochloride754%
Cardene Iv18%

By year

2026215%
2025215%
2024323%
202018%
201918%
2018215%
201518%
201318%

Ongoing nicardipine recalls

6 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Cardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene Iv	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
26 Aug 2026Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Particulate Matter	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride	American Regent	Sterility	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride	American Regent	Sterility	Nationwide
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per Vial recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) vials recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide

All nicardipine recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Cardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene Iv	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
26 Aug 2026Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Particulate Matter	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride	American Regent	Sterility	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride	American Regent	Sterility	Nationwide
29 May 2024Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride	American Regent	Sterility	UT
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per Vial recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) vials recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide
15 Apr 2020Drug	CLASS II	nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
1 May 2019Drug	CLASS II	NICARdipine 25 mg in NS Excel, Made by: Enterprise Pharmacy recalled	CMC Enterprise Pharmacy	Sterility	NC
28 Feb 2018Drug	CLASS II	Nicardipine HCl in all strengths, all doses, and all packaging recalled	Pharmedium Services	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Nicardipine HCl in 0.9% Sodium Chloride in all strengths recalled	Pharmedium Services	Sterility	Nationwide
25 Mar 2015Drug	CLASS III	Nicardipine Hydrochloride Injection, 25 mg recalled	Mylan Institutional	Potency & Assay	Nationwide
17 Jul 2013Drug	CLASS III	Nicardipine Hydrochloride Injection 25 mg recalledNicardipine Hydrochloride	West-ward Pharmaceutical	Potency & Assay	Nationwide

Should you stop taking Nicardipine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.