Hydralazine Hydrochloride Tablets Recalled Due to Failed Purity Tests
Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) due to failed impurity specifications discovered during 6-month stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving specification failures for impurities in a repackaged pharmaceutical product. No illnesses, injuries, or deaths have been reported. The classification reflects the product's failure to meet required quality standards, warranting precautionary action.
Plain-English summary
HydrALAZINE Hydrochloride Tablets, USP, 10 mg are being recalled nationwide. The recalled product is a 100-count unit dose carton with Lot Number 1012275 (expiration date 02/28/2025), distributed by American Health Packaging, Columbus, Ohio.
The recall was initiated because the repackaged product failed to meet FDA specifications for Related Compounds (impurities) at the 6-month stability testing point. This out-of-specification result indicates the product did not meet required quality standards for pharmaceutical purity and degradation.
Approximately 2,850 cartons were distributed nationwide throughout the United States.
Patients taking this medication should contact their pharmacy or healthcare provider for guidance regarding their prescription.
The recalled product
- Product
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Affected units
- 2,850
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1012275
- Exp 02/28/2025
Distribution
Distributed nationwide across the United States.
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