Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limit
Summary
The FDA issued a Class II for Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Ma by Inventia Healthcare Limited. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-0610-2026
Action Date
2026-06-24
Status
Ongoing
Category
drug
Product Description
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10
Lot/Code Info: [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Quantity Affected: 11,460 bottles
Reason for Recall
Failed Dissolution Specifications
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-05
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inventia Healthcare Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inventia Healthcare Limited have FDA actions?
This is the only FDA action we have on record for Inventia Healthcare Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0610-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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