FDA Classifies Chlorthalidone Recall After Tablets Fail Dissolution Tests

Overview

• The FDA has classified an ongoing recall of 13,567 bottles of chlorthalidone as Class II after laboratory testing found the tablets did not meet dissolution specifications.
• Dissolution failures mean the pill may not break down and release its active ingredient properly, which can lower absorption and make the medicine less effective at controlling blood pressure.
• The recalled 100-count bottles were manufactured by Inventia Healthcare Limited and distributed nationwide by Rising Pharma Holdings Inc.
• This is the second similar recall for the same manufacturer this year, following a smaller recall in June for tablets that also failed dissolution testing, raising concerns about recurring production-quality issues.
• Patients using chlorthalidone should check their bottle labels and batch numbers, consult their pharmacist or prescriber for safe alternatives, and follow return or disposal instructions from retailers or health authorities.