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

FDA recall notice · announced June 24, 2026 · Inventia Healthcare Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: U.S. Nationwide.
Lot/code information: [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Quantity: 11,460 bottles
Status: Ongoing
Products in this recall event:
- 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. Distribute (D-0610-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.