Chlorthalidone 25mg tablets failed dissolution specifications in two batches
Chlorthalidone Tablets, USP, 25 mg, are being recalled because they failed dissolution specifications. 11,460 bottles are affected.
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: FDA Class II recall for an out-of-specification dissolution result with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
Chlorthalidone Tablets, USP, 25 mg, in 100-tablet and 1,000-tablet bottles, prescription only, manufactured by Inventia Healthcare Limited in Ambernath, India and distributed by Rising Pharma Holdings, are being recalled. The action covers 11,460 bottles.
The stated reason is failed dissolution specifications. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected batches are RISA24001 for the 100-tablet bottle and RISB24002 for the 1,000-tablet bottle, both expiring 04/2027. Distribution was USA nationwide.
Patients should not stop taking a prescribed medicine without advice. Anyone holding an affected batch should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- CHLORTHALIDONE (CHLORTHALIDONE)
- Brand
- CHLORTHALIDONE
- Manufacturer
- Inventia Healthcare Limited
- Category
- Drug — Diuretic tablet
- Affected units
- 11,460
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 (3)
- [100 tablet bottle] Batch RISA24001
- [1000 tablet bottle] Batch RISB24002
- Exp. 04/2027
UPCs (3)
- 0364980599108
- 0364980599016
- 0364980600019
Distribution
Distributed nationwide across the United States.
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