Furosemide tablets recalled for presence of N-nitroso impurity
Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.
What this means for you
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: The FDA classified this as a Class II recall. The source text does not report any illnesses or injuries, and the hazard is a manufacturing impurity above a recommended limit rather than a structural or acute safety defect. This meets the threshold for a Moderate severity recall.
Plain-English summary
Leading Pharma, LLC is recalling Furosemide Tablets, USP, 80 mg (NDC 69315-118-01) due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. The recall is linked to Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process.
The affected product was distributed nationwide in the United States. The recall involves approximately 9,384 bottles with lot numbers H03125, H03225, and H03325, all with an expiration date of August 2027.
Patients taking the affected Furosemide tablets should contact their healthcare provider or pharmacist for guidance on obtaining a replacement product. Consumers who have this medication should not stop taking it without consulting their healthcare provider.
The recalled product
- Product
- FUROSEMIDE (FUROSEMIDE)
- Brand
- FUROSEMIDE
- Manufacturer
- Leading Pharma, LLC
- Hazard
- n-nitroso-impurity
- manufacturing-deviation
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 (4)
- Lots# H03125
- H03225
- H03325
- Exp Date: 2027/08
Distribution
Distributed nationwide across the United States.