Hydralazine HCl Tablets recall
FDA recall D-0045-2025 · initiated Nov 5, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Hydralazine HCl Tablets in Nov 2024 — an FDA Class III recall (D-0045-2025) because Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 25814 tablets
Details
- Product
- Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US.
- Initiated
- Nov 5, 2024
- FDA report date
- Nov 20, 2024
Frequently asked
- Was Hydralazine HCl Tablets recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Hydralazine HCl Tablets in Nov 2024 — an FDA Class III recall (D-0045-2025) because Failed Impurities/Degradation Specifications; during routine stability testing for impurities. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Hydralazine HCl Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0045-2025 was: Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
- Is a recalled Hydralazine HCl Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Hydralazine HCl Tablets are affected?
- Distributed: Nationwide in the US.. The recall covers these lots — Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0045-2025.