Overview
- Inventia Healthcare initiated a voluntary recall on Sept. 3 for 13,567 bottles of 25 mg chlorthalidone (batch RISA24002, NDC 64980-599-01, exp. Apr 2027) that were distributed nationwide.
- The FDA formally classified that September recall as Class II on Sept. 17, a designation that indicates the product may cause temporary or medically reversible health effects and that serious harm is unlikely.
- This is the second dissolution-related recall by Inventia in 2026, following a June recall of about 11,460 bottles, bringing the combined total to more than 25,000 bottles removed from U.S. distribution.
- Dissolution testing showed the tablets may not break down and release the active ingredient at the required rate, which can lower absorption and reduce the drug’s ability to control blood pressure over time.
- Patients are advised not to stop their medication without medical advice, to check prescription labels and lot numbers with their pharmacist or prescriber, and to report any problems to FDA MedWatch; the recalls have increased scrutiny of manufacturing quality controls for the supplier and distributor.