Hydralazine recalls

The FDA has published 15 recalls involving Hydralazine since 2014. The latest was reported on 20 Nov 2024. Most were for potency & assay. The Harvard Drug Group 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 recalls15since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 20 Nov 2024

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 11 73%Class III 4 27%

Why hydralazine is recalled

Companies

By year

2024427%
2023213%
202217%
201717%
2015213%
2014533%

Ongoing hydralazine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	HydrALAZINE HCl Injection, USP, 20 mg/mL Single Dose vials recalled	Akorn	Potency & Assay	Nationwide

All hydralazine recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
20 Nov 2024Drug	CLASS III	Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group	The Harvard Drug Group	Potency & Assay	Nationwide
21 Feb 2024Drug	CLASS II	HydrALAZINE Hydrochloride Tablets, USP 10mg recalled	The Harvard Drug Group	Potency & Assay	Nationwide
14 Feb 2024Drug	CLASS III	HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x per unit dose recalled	Amerisource Health Services	Potency & Assay	Nationwide
3 Jan 2024Drug	CLASS II	HydrALAZINE Hydrochloride Tablets, USP, 25 mg recalledHydralazine Hydrochloride	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
11 Oct 2023Drug	CLASS III	HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x recalled	Amerisource Health Services	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	HydrALAZINE HCl Injection, USP, 20 mg/mL Single Dose vials recalled	Akorn	Potency & Assay	Nationwide
23 Mar 2022Drug	CLASS II	hydrALAZINE HCl Tablets, USP, 10 mg per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
19 Apr 2017Drug	CLASS II	hydrALAZINE Hydrochloride Injection, USP, 20 mg/mL Single Dose Vial recalledHydralazine Hydrochloride	Mckesson Medical Surgical	Packaging Defects	Nationwide
19 Aug 2015Drug	CLASS III	Hydralazine Hydrochloride Injection, USP, 20 mg/mL fill recalledHydralazine Hydrochloride	Fresenius Kabi USA	Packaging Defects	Nationwide
14 Jan 2015Drug	CLASS II	HydrALAZINE Hydrochloride Tablets, USP 25 mg recalled	Par Pharmaceutical	Particulate Matter	Nationwide

Should you stop taking Hydralazine?

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.