National recall of chlorthalidone affects thousands of vials due to dissolution problems
Thousands of vials of a popular drug used to treat blood pressure have been withdrawn from circulation across the country. The reason is a possible manufacturing defect that could compromise the effectiveness of the medicine.
More than 11,400 bottles of chlorthalidone pills, a medication that requires a prescription, were included in this action, according to information from the US Food and Drug Administration (FDA).
Inventia Healthcare Limited, the drug’s Indian manufacturer, began a voluntary recall of specific batches of 25 mg chlorthalidone on June 5. The products, in bottles of 100 and 1,000 tablets, were distributed in the United States by Rising Pharma Holdings, Inc., based in New Jersey.
The measure was taken after tests indicated that certain batches of the drug “did not meet dissolution specifications”, as communicated by the FDA. This failure suggests that the tablets may not dissolve correctly in the body, compromising their therapeutic action.
On June 22, the FDA classified the recall as “Class II,” indicating a moderate risk. This classification means that the use of the recalled product may result in temporary or reversible adverse effects on the health of patients, as explained by the regulatory agency.
According to Medline Plus, chlorthalidone is a common diuretic prescribed to control high blood pressure and fluid retention. Its function is to assist the kidneys in eliminating excess water and salt from the body, which are excreted in the urine.
For those using blood pressure medications, it is recommended to check the label on the bottle itself.
Identification of chlorthalidone batches affected by the recall
About 11,460 vials of chlorthalidone, a prescription medication, were recalled from the market, according to information from the FDA.
The tablets were manufactured by Inventia Healthcare Limited, based in Mumbai, India. Each affected vial has a specific NDC (National Drug Code) code and lot number on its packaging.
The blood pressure products included in this recall action are:
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- Chlorthalidone Tablets, USP, 25 mg (100 tablets)
NDC: 64980-599-01
Lot: RISA24001
Expiration date: 04/2027
- Chlorthalidone Tablets, USP, 25 mg (1,000 tablets)
NDC: 64980-599-10
Lot: RISB24002
Expiration date: 04/2027
Rising Pharma Holdings, Inc., based in East Brunswick, New Jersey, was responsible for distributing the collected vials nationwide.
Instructions for patients using the recalled medicine
To date, the FDA has not released specific direct guidance for affected patients.
Individuals using 25 mg chlorthalidone tablets should carefully check the label on their bottle to confirm that it matches the description of the recalled products.
If it is suspected that your medicine has been affected by this recall, it is crucial to contact your doctor or pharmacist immediately to discuss next steps and receive appropriate advice.
It is essential to always consult a healthcare professional before stopping the use of any prescribed medication. Abruptly stopping blood pressure medications can cause side effects and pose serious health risks, as warned by the American Heart Association.
This incident marks the second recall of a commonly used blood pressure medication in less than a year. In October 2025, more than half a million bottles of Prazosin Hydrochloride were recalled due to concerns about the presence of unsafe levels of potentially carcinogenic chemicals in the capsules.
