FDA Issues Recall of 11,460 Bottles of Blood Pressure Drug Chlorthalidone

More than 11,000 bottles of a blood pressure medication have been recalled due to a manufacturing issue that could affect how well the drug works.

The recall was initiated on June 5 by Inventia Healthcare Limited, the India-based manufacturer of chlorthalidone tablets.

What Was Recalled and Why

The specific product involved is Chlorthalidone Tablets, USP, 25 mg.

The recall covers two bottle sizes: a 100-tablet bottle with NDC code 64980-599-01 and batch code RISA24001, and a 1,000-tablet bottle with NDC code 64980-599-10 and batch code ISB24002. All affected bottles carry an expiration date of April 2027. A total of 11,460 bottles are included in the recall.

According to the FDA's enforcement report, the recall was triggered by "failed dissolution specifications" — meaning the tablets did not break down as required during quality testing. The pills were manufactured by Inventia Healthcare Limited and distributed in the United States by Rising Pharma Holdings, Inc. of East Brunswick, New Jersey, as confirmed by NewsNation's reporting on the recall.

📰 Related: FDA Gives Alfredo Sauce Recall Its Most Serious Warning

What Failed Dissolution Actually Means

Dissolution is the process by which a tablet breaks down in the body so its active ingredient can be absorbed into the bloodstream.

When a medication fails dissolution testing, it means the tablet may not dissolve at the expected rate — which could result in too little of the drug being absorbed, reducing its effectiveness.

For chlorthalidone, which is a diuretic prescribed to treat high blood pressure and reduce fluid retention caused by heart, kidney, or liver disease, reduced effectiveness means blood pressure may not be adequately controlled. The FDA has not yet assigned a formal risk classification to this recall. According to WGN TV's reporting, no public press release has been issued by the FDA alongside the enforcement report entry.

📰 Related: COVID Vaccines Still Protect the Heart, New JAMA Study Finds

What Patients Should Do

The FDA has not issued specific consumer instructions for this recall, and no risk level has been assigned.

Stopping blood pressure medication abruptly without medical guidance can carry its own risks — the concern isn't simply swapping one drug for another.

Jennifer Young, PharmD, BCPS, lead medication safety specialist at the Institute for Safe Medication Practices, has advised that recall notifications can be alarming but should not prompt patients to stop taking medication without speaking to a healthcare provider first. The safest step is to check whether a bottle matches the recalled lot numbers and expiration date, then contact a doctor or pharmacist before making any changes to a medication routine.

📰 Related: Kennedy Orders Hantavirus Quarantine Despite CDC Guidance

How to Check If Your Medication Is Affected

Patients with chlorthalidone prescriptions can verify whether their bottle is part of the recall using the following identifiers:

The 100-tablet bottle carries NDC 64980-599-01 and batch code RISA24001. The 1,000-tablet bottle carries NDC 64980-599-10 and batch code ISB24002. Both sizes have an expiration date of April 2027.

If a bottle matches those details, patients are advised to contact their pharmacist or prescribing physician promptly.

Key Takeaways

• 11,460 bottles of Chlorthalidone Tablets, USP, 25 mg have been recalled by manufacturer Inventia Healthcare Limited, with distribution handled by Rising Pharma Holdings of New Jersey.

• The recall was initiated June 5 due to failed dissolution specifications — the tablets may not dissolve properly, potentially reducing the drug's effectiveness.

• Affected lots: 100-tablet bottles (NDC 64980-599-01, batch RISA24001) and 1,000-tablet bottles (NDC 64980-599-10, batch ISB24002), both expiring April 2027.

• The FDA has not assigned a risk classification to this recall and has not issued a consumer press release.

• Patients should not stop taking blood pressure medication without consulting a doctor or pharmacist first.

Sources

• FDA Enforcement Report — Chlorthalidone Tablets Recall

• NewsNation — Blood Pressure Medication Recalled Nationwide: FDA

• WGN TV — Blood Pressure Medication Recalled Nationwide Over Failed Dissolution Practices

• Cardiovascular Business — More Than 11K Bottles of Blood Pressure Drug Recalled

Also Read

• FDA Gives Alfredo Sauce Recall Its Most Serious Warning

• COVID Vaccines Still Protect the Heart, New JAMA Study Finds

• Kennedy Orders Hantavirus Quarantine Despite CDC Guidance