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More than 25,000 bottles of a blood pressure medication have been recalled due to potential dissolution issues. The U.S. Food and Drug Administration (FDA) announced that Inventia Healthcare Limited, based in Mumbai, India, is recalling 25-milligram chlorthalidone tablets after they failed dissolution tests. This failure could affect how the medication is absorbed by the body, potentially reducing its effectiveness.
The recall is split into two parts: over 11,000 bottles were recalled in June, and another 13,500 bottles were recalled in September. Both recalls have been classified as Class II by the FDA, indicating that the products could cause temporary or medically reversible health problems, but serious health consequences are unlikely. Patients taking the recalled medication should contact their doctor or pharmacist before making any changes to their treatment.
The latest recall, announced on September 3, involves 13,567 bottles of chlorthalidone tablets, with the FDA assigning it a Class II risk level on September 17. According to KGET 17 News, the affected batch has the number RISA24002 and an expiration date of March 2027. The June recall included batches RISA24001 and RISB24002, both expiring in April 2027.
Dissolution testing measures how well a drug releases its active ingredient. A failed result indicates that the product did not meet its required drug-release specifications, which could lead to reduced effectiveness in controlling blood pressure. According to Medical Daily, patients are advised to check the lot number on their bottles and consult their pharmacist for confirmation.
The FDA emphasizes that stopping medication without consulting a healthcare provider can be more harmful than continuing it, especially for those with high blood pressure. Patients should seek medical advice before making any changes to their treatment.