Inventia Healthcare Limited has voluntarily recalled over 25,000 bottles of 25 mg chlorthalidone blood pressure tablets following dissolution testing failures that could reduce drug absorption. The U.S. Food and Drug Administration classified the action as a Class II risk, indicating potential temporary or medically reversible health effects. Health officials advise patients using the medication not to stop treatment abruptly without consulting a doctor.
Details of the recalled drug batches
- ▪The recalled Inventia Healthcare Limited 25 mg chlorthalidone tablets carry batch numbers RISA24001, RISB24002, and RISA24002 with expiration dates of March or April 2027.
- ▪Inventia Healthcare Limited previously recalled 11,460 bottles of chlorthalidone tablets on June 5, 2026, bringing the total recalled across both actions to over 25,000 bottles.
- ▪Inventia Healthcare Limited voluntarily recalled 13,567 bottles of 25 mg chlorthalidone tablets on September 3, 2026 due to quality testing failures.
- ▪The Food and Drug Administration assigned recall numbers D-0610-2026 and D-0852-2026 to the Inventia Healthcare Limited chlorthalidone tablet recalls.
Reason for the recalls
- ▪Failure to meet dissolution specifications causes chlorthalidone tablets to break down improperly, potentially reducing the active dosage absorbed by the body.
- ▪Inventia Healthcare Limited initiated the recalls because the 25 mg chlorthalidone tablets failed quality testing by failing to meet required dissolution specifications.
FDA Class II risk classification
- ▪A Food and Drug Administration Class II risk classification signifies that exposure to a product may cause temporary or medically reversible adverse health consequences.
- ▪The Food and Drug Administration designated the Inventia Healthcare Limited chlorthalidone recall as a Class II risk level on September 17, 2026.
Guidance on recalled medications
- ▪The Food and Drug Administration advises patients not to stop taking recalled chlorthalidone without consulting a healthcare provider, as abrupt cessation can cause blood pressure to rise.
- ▪For Class II recalls, the Food and Drug Administration notes that consumers can generally continue taking the medication unless the recalling company provides different instructions.
CDC information on high blood pressure
- ▪The Centers for Disease Control and Prevention recommends managing high blood pressure through lifestyle choices such as regular physical activity, sodium restriction, and a healthy diet.
- ▪According to the Centers for Disease Control and Prevention, high blood pressure increases the risk of severe health problems including heart disease, stroke, and kidney disease.
- ▪Nearly 50% of adult Americans have high blood pressure, defined as a reading of 130 mm Hg/80 mm Hg or higher, according to the Centers for Disease Control and Prevention.
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