Reported Nov 20, 2024 · Terminated

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606

Is this the product you have?

  • Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton
  • Distributed byAvet Pharmaceuticals Inc., East Brunswick, NJ 08816
  • Distributed byMAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61
Lot codes and dates
    • Lot#: T04888
    • Exp 11/2024
    • T04946
    • Exp 12/2024
    • T04970
    • Exp 07/2025
Amount recalled
25814 tablets

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 16, 2025 · Data as of Sep 19, 7:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.