FDA recall D-0461-2025

AvKARE · Class II · drug

Product

Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide USA

Key facts

Status: Ongoing
Initiation date: 2025-05-09
Report date: 2025-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0461-2025