Class IIITerminated

Hydralazine HCl Tablets recall

FDA recall D-0045-2025 · initiated Nov 5, 2024

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.

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

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0045-2025 ↗

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