Nicardipine Hydrochloride recalls

Nicardipine Hydrochloride products have been recalled 7 times, most recently on 26 Aug 2026. The recalling company is usually American Regent. The most common reason is sterility.

Total recalls7since 2013

Last 12 months1reported

Class I00% of total

Ongoing5latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 2 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 1 0

Severity split

Class I 0 0%Class II 6 86%Class III 1 14%

Why nicardipine hydrochloride is recalled

Companies

Product types

Injectable & IV Drugs7100%

By year

2026114%
2025229%
2024343%
2013114%

Ongoing nicardipine hydrochloride recalls

5 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ 5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Particulate Matter	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection recalled by American RegentNicardipine Hydrochloride	American Regent	Sterility	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection recalled by American RegentNicardipine Hydrochloride	American Regent	Sterility	Nationwide
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection 5mg/mL), US, 25mg per Vial recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection, USP 25mg/mL 5 mg/mL) vials recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide

All nicardipine hydrochloride recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ 5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Particulate Matter	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection recalled by American RegentNicardipine Hydrochloride	American Regent	Sterility	Nationwide
7 May 2025Drug	CLASS II	niCARdipine Hydrochloride Injection recalled by American RegentNicardipine Hydrochloride	American Regent	Sterility	Nationwide
29 May 2024Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ 5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Sterility	UT
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection 5mg/mL), US, 25mg per Vial recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS II	Nicardipine Hydrochloride Injection, USP 25mg/mL 5 mg/mL) vials recalledNicardipine Hydrochloride	Eugia US	Potency & Assay	Nationwide
17 Jul 2013Drug	CLASS III	Nicardipine Hydrochloride Injection 25 mg/ 5 mg/mL) single-use vials recalledNicardipine Hydrochloride	West-ward Pharmaceutical	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.