US EditionGranules India Recalls Blood Pressure Medication Over Manufacturing Issues
CANADA, JUL 9 – Granules India recalled over 33,000 bottles of blood pressure medicine due to manufacturing defects that could affect patient safety, officials confirmed.
- In early July 2025, Granules India initiated a recall of over thirty-three thousand units of their Metoprolol Succinate extended-release tablets in the US due to manufacturing deficiencies.
- The recall was initiated after the product failed to satisfy the required dissolution standards during the six-month stability evaluation, as indicated by the USFDA.
- The medication was distributed by Granules Pharmaceuticals Inc., a US-based subsidiary, with affected lots manufactured in India and sold in 100- and 500-count bottles.
- The USFDA classified the recall as Class II, indicating minimal risk of serious health consequences and possible temporary or medically reversible effects.
- Following the announcement, Granules India’s shares declined slightly, and the recall highlighted ongoing quality challenges faced by Indian drugmakers in the US market.
12 Articles
12 Articles
The Hamilton Spectator
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The Food and Drug Administration on Tuesday upgraded a recall of a generic version of blood pressure medication metoprolol to its second-highest level because it failed to meet the FDA’s own criteria. The recall notice encompasses metoprolol succinate extended-release tablets in 25 milligram doses in 100-count and 500-count bottles. India-based Granules Pharmaceuticals Inc., the manufacturer, voluntarily recalled the medication, which is a beta-…
Granules India Recalls Blood Pressure Medication Over Manufacturing Issues
Granules India Recalls Blood Pressure Medication Over Manufacturing Issues Drug firm Granules India is undertaking a large-scale recall of its blood pressure lowering medication in the United States, prompted by manufacturing deficiencies. The company is recalling 33,024 bottles of Metoprolol Succinate tablets after failing to meet critical quality standards in stability tests.This recall pertains to the product failing to meet dissolution accep…
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