On September 17, 2026, the U.S. Food and Drug Administration (FDA) upgraded a national recall of 13,567 bottles of chlorthalidone 25 mg tablets to a Class II risk. This upgrade follows repeated dissolution testing failures, which indicate the medication may not release its active ingredients effectively into the body.
The affected medication is manufactured by Inventia Healthcare Limited, based in Mumbai, India, and distributed nationwide by Rising Pharma Holdings Inc., based in East Brunswick, New Jersey. Dissolution testing is a critical quality measure that ensures active pharmaceutical ingredients dissolve properly in liquid to allow for correct absorption by patients.
The FDA classifies a Class II recall as a situation where exposure to a product may cause temporary or medically reversible health issues, though the risk of serious long-term harm is considered remote. The initial recall notice was first issued on September 3, 2026.
Details of the Affected Chlorthalidone Lot
Patients and healthcare providers treating hypertension or fluid retention should check medicine cabinets for the following specific product:
- Product Name: Chlorthalidone Tablets, USP
- Strength: 25 mg
- Quantity: 13,567 bottles (100-count)
- Manufacturer: Inventia Healthcare Limited
- Distributor: Rising Pharma Holdings Inc.
- National Drug Code (NDC): 64980-599-01
- Batch / Lot Number: RISA24002
- Expiration Date: April 2027
Recurring Manufacturing Issues
This enforcement action is the second time in three months that chlorthalidone tablets from this manufacturing pipeline have failed dissolution quality controls. In June 2026, Rising Pharma Holdings recalled a separate batch of 11,460 bottles (lots RISA24001 and RISB24002) for the same reason.
These recurring failures highlight ongoing regulatory scrutiny regarding the consistency of overseas manufacturing and generic drug imports. Failed dissolution specifications remain a leading cause of pharmaceutical recalls in the United States.
What Dissolution Failure Means for Patients
Chlorthalidone is a thiazide diuretic, often called a “water pill.” Doctors prescribe it to treat hypertension (high blood pressure), which helps reduce the risk of strokes and heart attacks. It is also used to manage fluid retention caused by kidney disorders, liver cirrhosis, or congestive heart failure.
If a tablet fails dissolution tests, it may break down too slowly or irregularly in the stomach and intestines. This can lead to reduced drug effectiveness, meaning a patient’s blood pressure may remain uncontrolled even if they take the medication as prescribed.
Medical Guidance: Do Not Stop Medication Abruptly
While the efficacy of these pills is in question, medical professionals warn against stopping blood pressure medication suddenly. The American Heart Association notes that abrupt discontinuation can cause dangerous spikes in blood pressure, significantly increasing the immediate risk of a heart attack or stroke.
If you find a bottle that matches the recalled lot, follow these steps:
- Verify the lot number, NDC, and expiration date against official FDA databases.
- Contact your pharmacy or healthcare provider immediately to see if your supply is affected.
- Request a replacement prescription from a different manufacturer or an alternative medication.
- Continue taking your current dose under medical supervision until your doctor provides a safe transition plan.
Broader Quality Control Trends
This recall reflects a growing regulatory focus on generic drug supply chains. Federal authorities are increasingly penalizing suppliers that fail to ensure their products maintain chemical stability and bioavailability. As oversight increases, both domestic distributors and international manufacturers face higher pressure to eliminate quality deviations before products reach consumers.
