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4h ago

FDA Classifies Chlorthalidone Recall as Class II

The classification flags possible short-term health effects, prompting closer FDA review of generic dissolution testing.

More than 11,000 bottles of chlorthalidone tablets have been recalled because they failed “dissolution specifications”, according to a Food and Drug Administration notification. FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. 
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The FDA recalls Chlorthalidone Tablets, a blood pressure medication.

Overview

  • Inventia initiated a voluntary recall of its 25 mg chlorthalidone tablets on June 5, and the FDA updated the action to a Class II recall on June 22.
  • The recall covers 11,460 bottles sold nationwide in 100- and 1,000-count packages with NDCs 64980-599-01 and 64980-599-10, lot numbers RISA24001 and RISB24002, and April 2027 expiration dates.
  • The FDA says the batches failed dissolution specifications, which means the tablets did not reliably release their active ingredient at the tested rate and could deliver less consistent dosing.
  • Patients should not stop taking chlorthalidone without talking to a doctor or pharmacist, and pharmacies and clinicians can check NDCs and lot numbers to identify and remove affected stock.
  • This recall follows other recent dissolution-related actions for blood-pressure drugs and could lead to more testing of generic manufacturers and closer supply checks that may affect availability.