Hydralazine recalls
The FDA has published 17 recalls involving Hydralazine since 2014. The latest was reported on 12 Feb 2025. Most were for potency & assay. Aidapak Services 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 recalls 17 since 2014
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 3 latest 12 Feb 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%13 76%4 24%
Why hydralazine is recalled
Ongoing hydralazine recalls 3 active
All hydralazine recalls, newest first 17 total Reported Class Recall Company Reason Where 12 Feb 2025 Drug CLASS II HydrALAZINE Hydrochloride recalled by Sky Packaging SKY Packaging Potency & Assay Nationwide 12 Feb 2025 Drug CLASS II HydrALAZINE Hydrochloride , USP, 50mg recalled by Sky Packaging SKY Packaging Potency & Assay Nationwide 20 Nov 2024 Drug CLASS III Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group The Harvard Drug Group Potency & Assay Nationwide 21 Feb 2024 Drug CLASS II HydrALAZINE Hydrochloride Tablets, USP 10mg recalled The Harvard Drug Group Potency & Assay Nationwide 14 Feb 2024 Drug CLASS III HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x per unit dose recalled Amerisource Health Services Potency & Assay Nationwide 3 Jan 2024 Drug CLASS II HydrALAZINE Hydrochloride Tablets, USP, 25 mg recalled Cardinal Healthcare Manufacturing (CGMP) Deviations Nationwide 11 Oct 2023 Drug CLASS III HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 recalled Amerisource Health Services Potency & Assay Nationwide 7 Jun 2023 Drug CLASS II HydrALAZINE HCl Injection, USP, 20 mg/mL Single Dose vials recalled Akorn Potency & Assay Nationwide 23 Mar 2022 Drug CLASS II hydrALAZINE HCl Tablets, USP, 10 mg per carton ( blister packs) recalled The Harvard Drug Group Potency & Assay Nationwide 19 Apr 2017 Drug CLASS II hydrALAZINE Hydrochloride Injection, USP, 20 mg/mL Single Dose Vial recalled Hydralazine Hydrochloride Mckesson Medical Surgical Temperature Abuse Nationwide 19 Aug 2015 Drug CLASS III Hydralazine Hydrochloride Injection, USP, 20 mg/mL fill recalled Hydralazine Hydrochloride Fresenius Kabi USA Packaging Defects Nationwide 14 Jan 2015 Drug CLASS II HydrALAZINE Hydrochloride Tablets, USP 25 mg recalled Par Pharmaceutical Particulate Matter Nationwide 12 Feb 2014 Drug CLASS II Hydralazine HCL Tablets, USP, 50 mg in a single blister package recalled Teva Pharmaceuticals USA Potency & Assay Nationwide 12 Feb 2014 Drug CLASS II Hydralazine HCL Tablets, USP, 25 mg in a single blister package recalled Teva Pharmaceuticals USA Potency & Assay Nationwide 22 Jan 2014 Drug CLASS II hydrALAZINE HCl Tablet, 100 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II hydrALAZINE HCl Tablet, 50 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Hydralazine HCL Tablet, 25 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states
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.