Chlorthalidone Tablets Recalled for Temperature Storage Deviations
Cardinal Healthcare is recalling Chlorthalidone Tablets, 25mg (Batch 2107329UM) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.
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: This is an FDA Class II recall for a CGMP deviation involving temperature exposure outside labeled storage conditions. No illnesses, injuries, or adverse events have been reported. Per the rubric, precautionary recalls without reported harm and no Class I classification warrant a Moderate severity score.
Plain-English summary
Cardinal Healthcare is recalling Chlorthalidone Tablets, USP, 25mg (NDC: 43598-719-10, Batch 2107329UM) due to Current Good Manufacturing Practice (CGMP) deviations. The products were exposed to temperatures outside of the labeled storage conditions during manufacturing or distribution.
Chlorothalidone is a thiazide-like diuretic prescribed to treat high blood pressure and fluid retention. The recalled product was distributed nationwide.
Consumers in possession of the recalled product should consult with their pharmacist or healthcare provider about obtaining replacement medication. Do not use products from the affected batch.
The recalled product
- Product
- CHLORTHALIDONE (CHLORTHALIDONE)
- Brand
- CHLORTHALIDONE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Thiazide Diuretic
- Affected units
- 1
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 (1)
- Batch 2107329UM
UPCs (1)
- 0343598720012
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
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