Blood Pressure Drug Recall Hits Nearly 14,000 Medicines in US Under FDA’s ‘Adverse Health Consequences’ Risk

Inventia Healthcare Limited is voluntarily recalling 13,567 bottles of chlorthalidone tablets, a blood pressure medication, after the tablets failed dissolution specifications.

The recall covers 25 mg chlorthalidone tablets under NDC 64980-599-01, batch number RISA24002, with an expiration date of April 2027, distributed nationwide. Inventia Healthcare, based in Mumbai, India, initiated the recall on Sept. 3, and the FDA classified it as Class II on Sept. 17.

What Class II Means

A Class II classification applies to situations where a product may cause “temporary or medically reversible adverse health consequences,” a lower risk level than a Class I recall, which is used when a product could cause serious health consequences or death.

The move follows Inventia Healthcare’s June recall of 11,460 bottles of blood pressure medication that also failed to properly dissolve, The Hill reported on Monday.

Hypertension in the U.S.

Almost half of adult Americans have high blood pressure, according to the Centers for Disease Control and Prevention. Blood pressure readings of 130 mm Hg/80 mm Hg or higher can raise the risk of heart disease or stroke, the leading causes of death in the U.S.

High blood pressure can also lead to kidney disease, pregnancy-related complications, vision decline and dementia.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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