Last Updated on November 6, 2025 by The Health Master
Drug recall
Recently, five India’s leading pharmaceutical companies Glenmark, Granules India, Sun Pharma, Zydus and Unichem — have issued voluntary drug recall for their highly regulated U.S. market.
Such recalls, made public by the US Food and Drug Administration (USFDA), highlight how crucial maintaining quality in drug manufacturing truly is.
Know about the drug recall?
The reasons for these recall drugs are relatively varied but all pertain to basic quality and integrity standards of production.
According to the most recent Enforcement Report by the USFDA, issues range from physical errors, labeling mistakes to chemical deterioration.
Common problems that lead to drug recall are:
- Manufacturing errors: Issues that stem from the production process, in which a medication that’s produced has the wrong characteristics.
- Deterioration, impurity: When a medication begins to break down or has impurities, it may not be as effective or safe.
- Labeling issues: The most serious of all (also known as a container holding a different medicine or error of miscommunication).
Understand the drug recall?
The USFDA offers a classification system that ranks drug recall according to how they impact public health.
Class I Drug Recall: The most serious type of recall, a Class I drug recall means there is a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death. Therefore, Unichem’s voluntary recall due to a labeling error is considered a Class I drug recall; this is a major patient safety concern.
Class II Drug Recall: A Class II drug recall is where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse health consequences is remote. Glenmark, Sun Pharma, and Zydus’ recalls are in this category, important but less severe.
Class III Drug Recall: The least severe of all recalls, a Class III recall means the use of or exposure to a violative product is not likely to cause any adverse health consequences. Granules India’s recall is classified under a Class III action.
Details of drug recall
The list of Indian pharma recalls is a reminder that constant vigilance is needed to meet the stringent USFDA quality standards.
| Company | Product Recalled | Issue & Recall Class | Potential Health Risk |
| Glenmark Pharmaceuticals | Azelaic Acid Gel (13,824 tubes) | Gritty texture (Manufacturing Issue) Class II | Temporary/Reversible health issues (low risk of serious problems). |
| Granules India | Combination Drug for ADHD (Over 49,000 bottles) | Failed Impurity and Degradation Tests Class III | Unlikely to cause harm. |
| Sun Pharma | Renal Imaging Agent (1,870 kits) | Failed Dissolution Tests Class II | Temporary/Reversible health issues (low risk of serious problems). |
| Zydus Pharmaceuticals | Antiviral Drug Entecavir (8,784 bottles) | Impurity and Degradation Concerns Class II | Temporary/Reversible health issues (low risk of serious problems). |
| Unichem Pharmaceuticals | Unspecified Medicine (230 bottles) | Label Mix-up Class I | Most serious: Could lead to significant health risks if the wrong medicine is taken. |
Q: What does ‘Failed Dissolution Test’ mean?
A dissolution test determines whether a drug dissolves appropriately in time/at all in the human body.
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.
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