Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0904-6440-61 recalled?

HydrALAZINE Hydrochloride Tablets

Yes — this exact package was recalled

2 FDA recalls name the code 0904-6440-61 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.

Recalls naming this package

Class II · Moderate risk

HydrALAZINE Hydrochloride Tablets

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Terminated Impurity / degradation The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6440-61 D-0324-2024
Class II · Moderate risk

hydrALAZINE HCl Tablets

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

Terminated Impurity / degradation The Harvard Drug Group NDC 0904-6440-61 D-0653-2022

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler