CHLORTHALIDONE
Recalling Firm / Manufacturer: Inventia Healthcare Limited
(Kalyan, India)
FDA Recall Number: D-0610-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CHLORTHALIDONE
Generic Name
CHLORTHALIDONE
Active Substance(s)
Chlorthalidone
Administration Route
Oral
National Drug Code (NDC)
64980-599
Total Quantity Recalled
11,460 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Dissolution Specifications
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
June 24, 2026
Firm Initiation Date
June 05, 2026
FDA Classification Date
Jun 22, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0610-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508601UTCC