FDAFDA recall D-0610-2026 · Jun 24, 2026
Inventia Healthcare Limited: Chlorthalidone Tablets recall
Recall found
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
Reason for recall
Failed Dissolution Specifications
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
- Quantity
- 11,460 bottles
- Distribution
- U.S. Nationwide.
- Recalling firm
- Inventia Healthcare Limited, Kalyan
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-05
Source: openFDA enforcement record D-0610-2026 · search recall number D-0610-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.