Class II · Moderate risk
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
Hydralazine HCl Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
0904-6441-61
Compare with the code on your package — it is the most precise check available.
Drug: Hydralazine
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- NDC code
- 0904-6441-61
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0045-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydralazine recalls
See all
Class II · Moderate risk
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
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.
Class III · Low risk
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class III · Low risk
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Other recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
All 2024 recalls
Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
Class II · Moderate risk
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Class II · Moderate risk
Midodrine Hydrochloride Tablets
Defective container; inadequately sealed blister packaging.
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