11,460 bottles of blood pressure drug recalled by FDA

More than 11,000 bottles of a widely used blood pressure medication are being recalled. The recall follows a failed laboratory test. The U.S. Food and Drug Administration released details of the action on June 5. The recall covers 11,460 bottles of chlorthalidone tablets in total.

Inventia Healthcare Limited, based in India, manufactured the tablets. Rising Pharma Holdings, based in New Jersey, distributed them in the United States. Chlorthalidone works as a diuretic. It is also known as a “water pill.” Doctors prescribe it to treat high blood pressure and to reduce excess fluid from heart, kidney, or liver conditions.

Why the drug was recalled

The FDA reported that the tablets failed dissolution specifications. In simple terms, the tablets did not break down properly during testing. That failure raises concern that the drug may not work as intended once patients take it.

Because chlorthalidone treats blood pressure and fluid retention, proper dissolution is critical. Poor dissolution may reduce the drug’s effectiveness and limit its therapeutic benefit.

Details of the recalled product

The recall includes bottles in two sizes. Some contain 100 tablets. Others contain 1,000 tablets. All affected bottles carry an expiration date of April 2027.

The FDA has not yet assigned a classification to the recall. It has not labeled it Class I or Class II. That risk level remains under review.

Pattern of recent blood pressure drug recalls

This recall adds to a growing list of blood pressure medication issues flagged in recent months. Earlier recalls include a drug pulled after a failed test. Another recall involved nearly 600,000 bottles due to potential carcinogen contamination. A separate product was removed after black contaminants were found.

These repeated issues highlight ongoing quality concerns in parts of the generic drug supply chain. Some manufacturing problems involve dissolution failures. Others involve contamination risks.

Patients taking chlorthalidone should check their bottle’s lot number and expiration date. They should compare them with the FDA recall notice. They should also speak with a pharmacist or physician if they have concerns.

This article is for informational purposes only. It does not provide medical advice. Anyone with questions about a medication should contact a healthcare professional.

Source: Cardiovascular Business / FDA