Nisha Pandey

Health and Me

US FDA Recalls India-Made BP Drug For The Second Time In 3 Months: Here's Why

A <span>blood pressure medicine</span> manufactured in India has been recalled in the US for the second time in three months after a few batches failed a test designed to ensure that the drug dissolves properly in the body.

The medicine is <span>chlorthalidone</span> 25 mg, a commonly used diuretic, or 'water pill', manufactured by <span>Inventia Healthcare Limited</span> in India. The latest recall involves more than 13,500 bottles, while the earlier recall included 11,460 bottles. Both recalls have been classified by the <span>US Food and Drug Administration</span> (<span>FDA</span>) as Class II recalls.

<h2>India-Made BP Drug Recalled In The US For The Second Time </h2>

The <a href="https://www.healthandme.com/health-news/popular-organic-applesauce-recalled-due-to-mold-toxin-what-is-patulin-how-dangerous-it-is-article-156212951" data-type="tilCustomLink">US Food and Drug Administration</a> recalled chlorthalidone due to “failed dissolution specifications.” It means that when the tablet is swallowed, its active ingredient needs to dissolve at the right rate so the body can absorb the medicine.

If a tablet does not dissolve properly in the body, less of the active ingredient may become available for absorption, making the medicine less effective that it should be. 

For someone taking chlorthalidone to control high blood pressure, inadequate drug absorption could mean that blood pressure is not controlled as effectively as intended. The FDA has not reported contamination or a toxic ingredient as the reason for this particular recall.

Also read: <a href="https://www.healthandme.com/health-news/chlorthalidone-recall-fda-flags-second-india-made-blood-pressure-drug-article-154732718" data-type="tilCustomLink">Chlorthalidone Recall: FDA Flags Second India-Made Blood Pressure Drug</a>

<h2>Why Was The Drug Recalled Again?</h2>

The first recall was made by Inventia Healthcare on June 5, 2026, involving 11,460 bottles. A second, separate recall was initiated on September 3, involving another 13,567 bottles. The FDA classified this second recall as Class II on September 17.  Together, the two recalls affect more than 25,000 bottles of the medication.

The second recall has raised eyebrows as both issues were linked to the same type of manufacturing quality problem, which is failure to meet dissolution specifications.

The earlier recall involved batches RISA24001 and RISB24002. The latest recall involves 25 mg <a href="https://www.healthandme.com/health-news/broccoli-sprouts-linked-to-salmonella-outbreak-in-us-22-cases-reported-fda-says-article-156129871" data-type="tilCustomLink">chlorthalidone tablets</a>. Patients must check their medicine packaging for:

<ul><li>Manufacturer: Inventia Healthcare Limited</li><li>Strength: Chlorthalidone 25 mg</li><li>Batch: RISA24002</li><li>Expiry: April 2027</li><li>NDC: 64980-599-01 </li></ul>

Also read: <a href="https://www.healthandme.com/health-news/thyroid-medicine-recall-gets-us-fdas-highest-risk-rating-what-to-know-article-156221835" data-type="tilCustomLink">Thyroid Medicine Recall Gets US FDA’s Highest Risk Rating: What To Know</a>

<h2>More About Chlorthalidone &amp; Class II Recall</h2>

Chlorthalidone is a diuretic used to treat high blood pressure. It works mainly by helping the kidneys remove excess sodium and water from the body. This reduces the amount of fluid circulating through the blood vessels and helps lower blood pressure.

Keeping blood pressure under control is essential as untreated hypertension increases the risk of heart attack, stroke, heart failure and kidney disease.

A <a href="https://www.healthandme.com/health-news/us-fda-recalls-broccoli-amid-the-risk-of-listeria-outbreak-article-151168660" data-type="tilCustomLink">Class II recall</a> does not mean the medicine will cause serious harm in everyone who takes it. The FDA defines Class II recalls in which the affected product could cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. 

In this case, the concern is primarily that the affected tablets may not work as intended because of inadequate dissolution.

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<h2>What Should Patients Who Take This Medicine Do?</h2>

Patients should not stop the medication abruptly without speaking to a doctor or pharmacist. The FDA advises that people generally should not stop a recalled medicine without medical guidance, as suddenly stopping treatment for high blood pressure could be risky. 

If you take chlorthalidone, check the batch number on your bottle and contact your pharmacist or healthcare provider if it matches one of the recalled ones.

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A blood pressure medicine manufactured in India has been recalled in the US for the second time in three months after a few batches failed a test designed to ensure that the drug dissolves properly in the body.The medicine is chlorthalidone 25 mg, a commonly used diuretic, or 'water pill', manufactured by Inventia Healthcare Limited in India. The latest recall involves more than 13,500 bottles, while the earlier recall included 11,460 bottles. Both recalls have been classified by the US Food and Drug Administration (FDA) as Class II recalls.India-Made BP Drug Recalled In The US For The Second Time The US Food and Drug Administration recalled chlorthalidone due to “failed dissolution specifications.” It means that when the tablet is swallowed, its active ingredient needs to dissolve at the right rate so the body can absorb the medicine.If a tablet does not dissolve properly in the body, less of the active ingredient may become available for absorption, making the medicine less effective that it should be. For someone taking chlorthalidone to control high blood pressure, inadequate drug absorption could mean that blood pressure is not controlled as effectively as intended. The FDA has not reported contamination or a toxic ingredient as the reason for this particular recall.Also read: Chlorthalidone Recall: FDA Flags Second India-Made Blood Pressure DrugWhy Was The Drug Recalled Again?The first recall was made by Inventia Healthcare on June 5, 2026, involving 11,460 bottles. A second, separate recall was initiated on September 3, involving another 13,567 bottles. The FDA classified this second recall as Class II on September 17.  Together, the two recalls affect more than 25,000 bottles of the medication.The second recall has raised eyebrows as both issues were linked to the same type of manufacturing quality problem, which is failure to meet dissolution specifications.The earlier recall involved batches RISA24001 and RISB24002. The latest recall involves 25 mg chlorthalidone tablets. Patients must check their medicine packaging for:Manufacturer: Inventia Healthcare LimitedStrength: Chlorthalidone 25 mgBatch: RISA24002Expiry: April 2027NDC: 64980-599-01 Also read: Thyroid Medicine Recall Gets US FDA’s Highest Risk Rating: What To KnowMore About Chlorthalidone & Class II RecallChlorthalidone is a diuretic used to treat high blood pressure. It works mainly by helping the kidneys remove excess sodium and water from the body. This reduces the amount of fluid circulating through the blood vessels and helps lower blood pressure.Keeping blood pressure under control is essential as untreated hypertension increases the risk of heart attack, stroke, heart failure and kidney disease.A Class II recall does not mean the medicine will cause serious harm in everyone who takes it. The FDA defines Class II recalls in which the affected product could cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. In this case, the concern is primarily that the affected tablets may not work as intended because of inadequate dissolution.   What Should Patients Who Take This Medicine Do?Patients should not stop the medication abruptly without speaking to a doctor or pharmacist. The FDA advises that people generally should not stop a recalled medicine without medical guidance, as suddenly stopping treatment for high blood pressure could be risky. If you take chlorthalidone, check the batch number on your bottle and contact your pharmacist or healthcare provider if it matches one of the recalled ones.

us fda recalls india-made bp drug for the second time in 3 months: here's why

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