More than 11,000 bottles of a commonly prescribed blood pressure medication have been recalled across the United States after testing found the tablets may not dissolve properly, potentially affecting how well the medication works.
According to the U.S. Food and Drug Administration (FDA), India-based Inventia Healthcare Limited voluntarily recalled approximately 11,460 bottles of Chlorthalidone Tablets USP, 25 mg, after certain lots failed dissolution specifications during quality testing.
The voluntary recall was initiated on June 5 and later classified by the FDA as a Class II recall on June 22.
Why the Medication Was Recalled
The FDA said the affected tablets failed dissolution specifications, meaning they may not dissolve in the body at the intended rate.
When a medication does not dissolve properly, it may not release the correct amount of the active ingredient into the bloodstream, potentially reducing its effectiveness.
The FDA classifies a Class II recall as one involving products that may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious health effects is considered remote.
Which Products Are Affected?
The recall includes Chlorthalidone Tablets USP, 25 mg, distributed nationwide by Rising Pharma Holdings Inc., based in East Brunswick, New Jersey.
The affected products include:
100-count bottles
- NDC: 64980-599-01
- Lot number: RISA24001
- Expiration date: April 2027
1,000-count bottles
- NDC: 64980-599-10
- Lot number: RISB24002
- Expiration date: April 2027
In total, approximately 11,460 bottles are included in the recall.
What Is Chlorthalidone?
Chlorthalidone is a prescription diuretic, commonly known as a “water pill,” that is used to treat high blood pressure and reduce fluid retention caused by conditions such as heart failure, kidney disease, and liver disease.
The medication works by helping the kidneys remove excess salt and water from the body, reducing blood pressure and swelling.
What Patients Should Do
The FDA has not issued specific instructions for patients beyond the recall notice.
Anyone who takes 25-milligram chlorthalidone tablets should check the label on their prescription bottle to determine whether it matches one of the recalled lot numbers.
Patients who believe they have recalled medication should contact their pharmacist or healthcare provider to discuss obtaining a replacement or alternative treatment.
Health experts advise patients not to stop taking prescribed blood pressure medication without first consulting a healthcare professional, as abruptly discontinuing treatment can increase the risk of serious complications, including dangerously high blood pressure, heart attack, or stroke.
Latest in a Series of Blood Pressure Drug Recalls
The chlorthalidone recall follows other recent recalls involving blood pressure medication. In May, thousands of tablets of Enalapril Maleate were recalled after testing identified impurities in certain lots. In October, more than 500,000 bottles of Prazosin hydrochloride were recalled over concerns that the pills may contain unsafe levels of cancer-causing chemicals.
While recalls involving prescription medications remain relatively uncommon, the FDA encourages patients to review recall notices carefully and work with their healthcare providers whenever a prescribed medication is affected.
