FDA recall D-0610-2026

Inventia Healthcare Limited · Class II · drug

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

Distribution

U.S. Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-06-05
Report date
2026-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kalyan, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2026