Last Updated on July 31, 2025 by The Health Master
Drug recall
Hyderabad-based pharmaceutical giant Granules India is currently undertaking a drug recall of its generic blood pressure-lowering drug, Metoprolol Succinate extended-release tablets, from the US market.
The company has recalled over 33,000 bottles, due to manufacturing issues identified during stability testing.
The reason for the Drug Recall:
The US Food and Drug Administration (USFDA) has highlighted “failed dissolution specifications” as the primary reason behind Granules India’s drug recall.
The dissolution test is an important quality control measure for pharmaceutical products, ensuring that a tablet or capsule releases its active drug ingredient at the correct rate within the body.
In this case, the Metoprolol Succinate extended-release tablets failed to meet the mandatory dissolution specification during stability studies.
This suggests that over time, the drug may not release the active ingredient as intended, potentially affecting its efficacy in controlling blood pressure.
Details of the Drug Recall:
The drug recall involves 33,024 bottles of Metoprolol Succinate extended-release tablets.
These bottles are distributed in both 100-count and 500-count configurations.
The affected lots were manufactured in India by Granules India and subsequently distributed by its US-based subsidiary, Granules Pharmaceuticals Inc.
Understanding a Class II Drug Recall:
According to the USFDA, a Class II drug recall is initiated when “the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.”
Steps taken by Granules India
Granules India initiated this nationwide Class II drug recall on June 24.
This proactive measure demonstrates the company’s compliance with regulatory standards and its commitment to addressing quality concerns.
The Importance of Pharmaceutical Quality Control
This drug recall gives a reminder of the importance of stringent quality control measures within the pharmaceutical industry.
Starting from raw material testing to manufacturing processes, including the testing of the final product, every step is important to ensure the safety and efficacy of drugs.
Dissolution testing, as highlighted in this case, is just one of many rigorous tests pharmaceuticals undergo to guarantee they deliver their intended therapeutic effect consistently.
Failures in these tests, even if they lead to “minimal” risk, erode patient confidence and necessitate costly and disruptive recalls.
Q. Understanding a Class II Drug Recall ?
A. According to the USFDA, a Class II drug recall is initiated when “the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.”
Q. What should patients do during a drug recall?
A. Do not stop taking your medicine without consulting your doctor. Discontinuing blood pressure drug can be dangerous and lead to a sudden increase in blood pressure. Contact your healthcare provider. Discuss this drug recall with your doctor or pharmacist. Stay informed. Follow updates from your healthcare provider and official sources.
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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