More than 13,500 bottles of the widely prescribed blood pressure medication chlorthalidone are being recalled nationwide after the tablets failed an FDA dissolution test — the second time in three months that the same manufacturer has pulled the drug from U.S. shelves. The U.S. Food and Drug Administration (FDA) recently elevated the voluntary recall to a Class II designation, signaling that the affected pills may not dissolve, and therefore may not work, as intended.

The recall covers 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg, sold in 100-count and 1,000-count bottles under NDC 64980-599-01. The affected batch is labeled RISA24002 and carries an expiration date of April 2027. Manufacturer Inventia Healthcare Limited, based in Mumbai, India, initiated the recall on Sept. 3 after routine quality testing showed the tablets had "failed dissolution specifications."

How the Chlorthalidone Recall Unfolded: What We Know

Chlorthalidone is a thiazide-like diuretic — a "water pill" — that doctors prescribe to treat high blood pressure and reduce fluid retention, or edema, linked to heart, kidney, and liver conditions. It works by helping the body flush out excess salt and water through urine, which lowers blood pressure over time. Because the medication is taken daily by millions of Americans, any quality lapse draws quick attention from regulators and patients alike.

The recalled tablets were distributed nationwide by Risiong Pharma Holdings, Inc. According to the FDA, the problem is not contamination or toxicity. Instead, the tablets failed to meet dissolution specifications, which means they may not break down properly in the digestive tract. When a tablet dissolves too slowly or incompletely, the body absorbs less of the active ingredient, potentially leaving blood pressure less controlled than a patient's prescription intends.

Public health experts stress that the risk is one of reduced effectiveness rather than acute danger. The FDA assigned the recall its second-highest severity level, Class II, which the agency defines as a situation in which use of the product "may cause temporary or medically reversible adverse health consequences" but where the likelihood of serious harm is low.

Timeline: From First Recall to Class II Designation

  • June 5, 2026 — The FDA announces that Inventia Healthcare is recalling 11,460 bottles of chlorthalidone 25 mg tablets for the same failed dissolution specifications issue.
  • Sept. 3, 2026 — Inventia Healthcare initiates a second, larger recall covering 13,567 bottles of chlorthalidone 25 mg (batch RISA24002, expiration April 2027).
  • Sept. 17, 2026 — The FDA formally classifies the September recall as Class II.
  • Late September 2026 — National news coverage spreads, prompting patients to check their medicine cabinets for batch RISA24002.

Combined, the two recalls affect more than 25,000 bottles of the same 25 mg strength, raising questions about quality control at the manufacturing site.

Why Dissolution Testing Matters for Your Blood Pressure

Dissolution testing is a routine but critical quality-control step that measures how quickly and completely a tablet dissolves under conditions that mimic the human digestive system. For an immediate-release drug like chlorthalidone, the active ingredient must dissolve within a set window so it can enter the bloodstream and do its job.

When a batch fails this test, the practical concern is under-dosing — the medicine may be less effective at keeping blood pressure in a healthy range. For patients managing hypertension, silently under-treated blood pressure can raise long-term risks for heart attack, stroke, and kidney damage. That is why regulators move quickly to pull non-conforming lots, even when the pills are not toxic.

The recall is also a reminder that medication alone is only one piece of the blood-pressure puzzle. Cardiologists and dietitians emphasize that diet, movement, and daily habits can meaningfully support — and sometimes reduce the need for — blood pressure drugs.

Natural Ways to Support Healthy Blood Pressure

While no one should stop or change a prescription without talking to a doctor, everyday habits can help keep blood pressure in check and strengthen heart health:

  • Follow the DASH diet. The Dietary Approaches to Stop Hypertension eating plan emphasizes fruits, vegetables, whole grains, lean proteins, and low-fat dairy while limiting sodium, added sugar, and saturated fat.
  • Cut back on sodium. Most adults should aim for less than 2,300 mg of sodium per day — ideally closer to 1,500 mg for those with high blood pressure. Cooking at home and reading labels helps.
  • Eat more potassium-rich foods. Bananas, avocados, spinach, sweet potatoes, oranges, and beans help counterbalance sodium's effect on blood pressure.
  • Move most days. Aim for at least 150 minutes of moderate activity weekly — brisk walking, cycling, or swimming — plus strength training twice a week.
  • Maintain a healthy weight. Losing even a few pounds can lower blood pressure, especially when combined with regular exercise.
  • Limit alcohol and manage stress. Cutting back on drinking, prioritizing sleep, and practicing relaxation techniques such as deep breathing can all support healthier readings.

Where Things Stand Now

As of late September 2026, the recall remains active, and no injuries or adverse events have been linked to the affected tablets. The FDA advises patients taking chlorthalidone to check the label on their bottle for batch number RISA24002 and expiration date 04/2027. If your medication matches, contact your pharmacist or healthcare provider about a replacement or alternative.

Critically, health officials warn against stopping blood pressure medication on your own. Abruptly discontinuing chlorthalidone can trigger a dangerous rebound spike in blood pressure. The safer path is to continue taking your medication while arranging a switch with your provider.

What Happens Next

Inventia Healthcare is expected to complete the removal of the affected lots from the supply chain while regulators review the manufacturing process that produced two failed batches in a single quarter. For patients, the focus shifts to continuity of care: most pharmacies can substitute an unaffected lot or an equivalent blood pressure medication with a new prescription.

Longer term, the episode may prompt closer scrutiny of generic thiazide diuretics and could renew conversations about how lifestyle changes can reduce dependence on medication for millions of people with mild to moderate hypertension.

The Bottom Line: Key Takeaways

  • The FDA recalled 13,567 bottles of chlorthalidone 25 mg (batch RISA24002, NDC 64980-599-01, exp. 04/2027) after the tablets failed dissolution testing.
  • The recall is Class II — a risk of reduced effectiveness rather than toxicity — and is the second chlorthalidone recall from Inventia Healthcare in three months.
  • Patients should check their bottle, not stop the drug abruptly, and contact a pharmacist or doctor if their batch matches.
  • Diet, exercise, lower sodium, and healthy daily habits can meaningfully support blood pressure control alongside medication.