Overview
- Inventia Healthcare voluntarily recalled 13,567 bottles of 25 mg chlorthalidone tablets from batch RISA24002 on Sept. 3 after the tablets failed dissolution specifications, and the FDA classified that action as a Class II recall on Sept. 17.
- This September recall follows a separate June recall of about 11,460 bottles for the same dissolution failure, bringing the combined total to more than 25,000 recalled bottles.
- Dissolution testing measures how quickly a tablet breaks down to release its active ingredient, and failure can reduce absorption so the drug may not control blood pressure as intended.
- Health authorities advise patients to check lot and NDC numbers on their prescriptions, contact their pharmacist or prescriber before making any changes to therapy, and avoid abruptly stopping medication without medical guidance.
- Pharmacies should quarantine affected lots and report problems to the FDA’s MedWatch program, and regulators and reporters say the repeated dissolution failures this year raise concerns about manufacturing quality controls and possible downstream supply effects.