FDA Drugs recall ·
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle… recall
- Recall number
- D-0610-2026
- Date
- (initiated June 5, 2026)
- Company / brand
- Inventia Healthcare Limited
Additional Ambernath Midc, Kalyan, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,460 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Failed Dissolution Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Distribution
U.S. Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0610-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.