Enalapril Maleate 20 mg tablets recalled for out-of-specification impurities
JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate 20 mg tablets nationwide due to out-of-specification results in organic impurities testing. Affected lot GEH25023 was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II recall with no reported illnesses or injuries. The hazard is out-of-specification impurities in a blood pressure medication, which represents a manufacturing defect but falls under voluntary precautionary recall criteria in the absence of adverse health reports.
Plain-English summary
JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate Tablets, USP, 20 mg (1,000-count bottles, NDC 64980-688-10) distributed by Rising Pharma Holdings, Inc. The recall affects 675 bottles nationwide distributed to the USA.
The recall is due to out-of-specification results in organic impurities testing. Lot GEH25023, expiring 6/30/2027, failed to meet impurities and degradation specifications.
Patients currently taking this medication should contact their healthcare provider or pharmacist about whether they have affected product and whether they should continue their medication. Consumers should not stop taking their blood pressure medication without consulting a healthcare provider. Pharmacies should cease distribution of the recalled lot immediately and return or destroy product according to instructions from their distributor.
The recalled product
- Product
- ENALAPRIL MALEATE (ENALAPRIL MALEATE)
- Brand
- ENALAPRIL MALEATE
- Manufacturer
- JB Chemicals and Pharmaceuticals Ltd
- Affected units
- 675
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 #: GEH25023
- Expires: 6/30/2027
Distribution
Distributed nationwide across the United States.
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