Last Updated on August 28, 2025 by The Health Master
Drug recall:
In a move to ensure patient safety, Sun Pharmaceutical Industries, Inc., the U.S. arm of the global pharmaceutical giant, has initiated a voluntary nationwide drug recall of spironolactone tablets.
The reason? The discovery of a foreign substance—specifically, aluminum—in the drug.
This drug recall, categorized by the U.S. Food and Drug Administration (USFDA) as a Class II drug recall, affects thousands of bottles across the country.
Reason for this drug recall?
The recall focuses on Spironolactone tablets manufactured for Sun Pharma by Philadelphia-based Frontida BioPharm.
The problem was first identified when a foreign substance was found within the tablets. Subsequent testing confirmed that the substance was aluminum.
In total, a staggering 11,328 bottles of the drug are being pulled from the shelves.
The company officially started this voluntary drug recall on August 5, 2025, and it has since been classified as a Class II drug recall.
It means that while the issue is serious, the potential for medically reversible adverse health consequences is considered temporary, and the likelihood of serious harm is low.
However, this doesn’t diminish the importance of the drug recall, as it’s a critical step in maintaining the safety and integrity of the drug supply.
Why Is This Drug Recall Important?
Spironolactone is an important drug used to treat several serious health issues.
It’s often prescribed for:
High blood pressure (hypertension): It helps lower blood pressure by working on the kidneys.
Heart failure: It reduces fluid overload, which is a major symptom of heart failure.
Edema (swelling): It helps the body get rid of excess water and sodium.
The drug is an aldosterone antagonist, meaning it blocks a hormone called aldosterone in the kidneys.
This action helps to increase water excretion, which in turn reduces fluid buildup and lowers blood pressure.
Q: What is a Class II Drug Recall?
A Class II drug recall is a USFDA classification for products that could cause temporary or medically reversible health problems. It indicates that the potential for serious health issues is remote, but the drug is still being removed from the market to prevent any potential harm.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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