Hydralazine Tablets Recalled Due to Failed Impurities and Degradation Testing
Hydralazine HCl Tablets 25mg are recalled nationwide due to failed impurities and degradation specifications. The recall affects approximately 25,814 tablets distributed by Avet Pharmaceuticals and MAJOR Pharmaceuticals.
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: FDA Class III recall for failed quality specifications (impurities and degradation) discovered during routine stability testing with no reported illnesses or injuries.
Plain-English summary
Hydralazine HCl Tablets, USP 25mg, are being recalled nationwide. The recall was initiated because the medication failed impurities and degradation specifications discovered during routine stability testing. The affected medication was manufactured by The Harvard Drug Group LLC (operating as Major Pharmaceuticals and Rugby Laboratories) and distributed by Avet Pharmaceuticals Inc. (East Brunswick, NJ) and MAJOR Pharmaceuticals (Livonia, MI).
The recall affects approximately 25,814 tablets across three lot numbers: T04888 (expires 11/2024), T04946 (expires 12/2024), and T04970 (expires 07/2025). The medication was distributed nationwide in the United States.
If you are taking this medication from an affected lot, contact your healthcare provider or pharmacist to discuss your treatment options. Return any recalled medication to your pharmacy or contact the recalling firm for instructions.
The recalled product
- 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.
- Category
- Drug
- Hazard
- Affected units
- 25,814
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 (6)
- Lot#: T04888
- Exp 11/2024
- T04946
- Exp 12/2024
- T04970
- Exp 07/2025
Distribution
Distributed nationwide across the United States.
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