FDA Elevates Chlorthalidone Recall to Class II After Repeated Dissolution Failures

Overview

• Inventia Healthcare issued two voluntary recalls this year after tablets failed dissolution testing, first in June and again on Sept. 3 for the newer lot.
• The two recalls together cover more than 25,000 bottles, with the September action affecting about 13,567 bottles of 25 mg chlorthalidone in 100-count bottles.
• The September affected lot is identified as RISA24002 (NDC 64980-599-01, exp. 04/2027) and earlier recalled lots include RISA24001 and RISB24002, all distributed nationwide by Rising Pharma Holdings.
• The FDA classified the September recall as Class II on Sept. 17, meaning the product may cause temporary or medically reversible health effects because poor dissolution can reduce drug absorption and effectiveness.
• Regulators and the manufacturer advise patients to check lot numbers with their pharmacist, do not stop or change medication without talking to a clinician, and report any problems to the FDA’s MedWatch program.