Chlorthalidone Tablets Recalled Due to Failed Dissolution Specifications
AvKARE is recalling Chlorthalidone Tablets USP 25 mg due to failed dissolution specifications. The defect may affect the drug's therapeutic effectiveness.
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. The source states no illnesses or injuries have been reported, and the hazard is a manufacturing defect (failed dissolution) rather than contamination or a high-risk pathogen. Per the rubric, voluntary precautionary recalls and manufacturing defects without reported harm are typically scored as Moderate (2).
Plain-English summary
AvKARE is recalling Chlorthalidone Tablets, USP, 25 mg (Lot #47947, expiration 05/31/2026) due to failed dissolution specifications. The product is a prescription diuretic medication used to manage blood pressure and fluid retention.
The affected product consists of 962 cartons distributed nationwide. Each carton contains 50 tablets in unit dose cards (5x10). The NDC is 50268-167-15, manufactured for AvKARE, Pulaski, TN 38478.
Dissolution is the rate at which a tablet breaks down and releases its active ingredient in the body. Failed dissolution specifications mean the tablets may not dissolve at the expected rate, potentially affecting how much of the drug is available for absorption and reducing its therapeutic effectiveness.
Patients taking this medication should not stop treatment without consulting their healthcare provider. Individuals with affected product should contact their pharmacy or healthcare provider for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- CHLORTHALIDONE (CHLORTHALIDONE)
- Brand
- CHLORTHALIDONE
- Manufacturer
- AvKARE
- Category
- Drug — Prescription Oral Tablet
- Affected units
- 962
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 # 47947
- Exp 05/31/2026
Distribution
Distributed nationwide across the United States.
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Similar recalls
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