The FDA has expanded a Class II recall of chlorthalidone after additional bottles failed dissolution testing. The action affects 13,567 bottles manufactured by Inventia Healthcare Limited with an April 2027 expiration date and follows an earlier recall of more than 11,000 bottles. Patients should check bottles for the manufacturer and expiration date and contact their pharmacy or clinician if theirs match the recalled product; do not stop medication without medical advice.
FDA Expands Chlorthalidone Recall After Additional Tablets Fail Dissolution Tests — 13,567 Bottles Affected
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The U.S. Food and Drug Administration has expanded a Class II recall for chlorthalidone after additional bottles were found to contain tablets that fail dissolution testing. The issue affects specific lots manufactured by Inventia Healthcare Limited and is a tablet performance problem rather than a contamination or labeling error.
What the recall covers
The expanded recall covers 13,567 bottles of chlorthalidone made by Inventia Healthcare Limited that carry an April 2027 expiration date. The FDA classified the action as Class II, indicating a moderate health risk related to the tablets’ reduced ability to dissolve and release the active drug as expected.
Why this matters
When tablets do not dissolve properly they may deliver less medication than intended, which can reduce treatment effectiveness. For people taking chlorthalidone for high blood pressure, reduced drug release could raise the risk of uncontrolled blood pressure and its complications.
What patients should do
Check any chlorthalidone bottles you have on hand. Verify the manufacturer (Inventia Healthcare Limited) and the April 2027 expiration date referenced in the recall. If your bottle matches those details, contact your dispensing pharmacy or prescribing clinician as soon as possible to arrange for replacement or guidance. Do not stop or change your blood pressure medication without consulting a healthcare professional.
If you experience possible treatment failure (for example, a sudden increase in blood pressure or symptoms like severe headache or chest pain), seek medical attention. You can report adverse events or quality problems to the FDA’s MedWatch safety reporting program.
Broader context
This update follows an earlier recall of more than 11,000 bottles of the same product. It also comes amid other recent drug recalls, including a Breckenridge Pharmaceuticals recall of duloxetine after tests found a cancer-linked impurity above acceptable limits, a U.S. recall affecting more than 2 million bottles of prednisolone (where patients were warned not to stop treatment abruptly), and the FDA’s removal of nearly 900,000 epinephrine vials after laboratory testing identified impurities and degradation.
Public reaction
Comments on social posts about the recall included expressions of broader mistrust of prescription drugs. While public concern is understandable, clinicians and regulators advise following official guidance: check your medication, contact your pharmacy or prescriber, and rely on healthcare professionals rather than social media for treatment decisions.
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