Chlorthalidone Tablets Recalled for Failed Dissolution Specifications
AvKARE is recalling Chlorthalidone Tablets, USP 25 mg, due to failed dissolution specifications. Patients taking this blood pressure medication should contact their pharmacy about the affected lot.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription diuretic. Although no illnesses or injuries have been reported, failed dissolution creates a risk of inadequate medication efficacy for patients with hypertension, a serious chronic condition requiring reliable drug delivery.
Plain-English summary
AvKARE is recalling 962 cartons of Chlorthalidone Tablets, USP, 25 mg, Rx only. The product is supplied in unit dose cards (50 tablets per carton, 5x10 configuration).
The tablets do not meet dissolution specifications, which means they may not dissolve properly in the body. This could result in inadequate drug delivery and reduced effectiveness of the blood pressure medication.
The recalled product was distributed nationwide under Lot #47947 with an expiration date of 05/31/2026. Affected consumers should contact their pharmacy or healthcare provider if they have received this product.
Patients should not stop taking their blood pressure medication without consulting their healthcare provider. They should ask their pharmacy whether their Chlorthalidone supply is affected by this recall and discuss alternative treatment options if needed.
The recalled product
- Product
- CHLORTHALIDONE (CHLORTHALIDONE)
- Brand
- CHLORTHALIDONE
- Manufacturer
- AvKARE
- Category
- Drug
- Hazard
- dissolution-failure
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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