Why Are Glenmark, Granules, Zydus and Others Recalling Medicines in the US Due to Quality Issues?
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Synopsis
Multiple Indian pharmaceutical companies are recalling their products in the US due to various quality issues, including impurities and labeling errors. With Glenmark, Granules, Zydus, and others involved, this situation raises concerns about medication safety. Discover the details behind these recalls and their implications for consumers.
Key Takeaways
- Glenmark recalls 13,824 tubes of Azelaic Acid Gel due to gritty texture complaints.
- Granules India recalls over 49,000 ADHD medication bottles for failing impurity tests.
- Sun Pharma recalls 1,870 renal imaging kits after dissolution test failures.
- Zydus Pharmaceuticals recalls 8,784 Entecavir tablets due to impurity concerns.
- Unichem Pharmaceuticals issues a Class I recall for 230 bottles due to labeling errors.
New Delhi, Sep 28 (NationPress) A number of Indian pharmaceutical firms, including Glenmark, Granules India, Sun Pharma, Zydus, and Unichem, are in the process of recalling their products from the US market, as reported by the US Food and Drug Administration (USFDA).
The reasons for these recalls stem from manufacturing problems, impurities, and labeling mistakes, as detailed in the regulator's most recent Enforcement Report.
Glenmark Pharmaceuticals is recalling 13,824 tubes of Azelaic Acid Gel, manufactured at its facility in Goa, due to reports of a gritty texture.
The company’s US division initiated a Class II nationwide recall on September 17, indicating that while the product might cause temporary or reversible health issues, the likelihood of serious problems is minimal.
Granules India is also recalling over 49,000 bottles of a combination medication for attention deficit hyperactivity disorder (ADHD).
This recall was triggered on August 28 by its US division after the product did not pass impurity and degradation tests.
This is classified as a Class III recall, meaning the likelihood of causing harm is low.
Sun Pharma’s US subsidiary has recalled 1,870 kits of a renal imaging agent following unsatisfactory dissolution tests. This Class II recall was announced on September 3.
Similarly, Zydus Pharmaceuticals (USA) Inc, part of the Ahmedabad-based Zydus, is recalling 8,784 bottles of the antiviral drug Entecavir tablets due to concerns over impurities and degradation.
This recall, also classified as Class II, was initiated on September 4. Unichem Pharmaceuticals USA Inc has issued a Class I recall for 230 bottles of medicine due to a labeling error.
The company, located in East Brunswick, began the recall on August 27. A Class I recall is deemed the most serious, as it might pose significant health risks if the incorrect medicine is consumed.
It’s worth noting that India boasts the highest number of USFDA-approved pharmaceutical plants outside the United States.
Point of View
It's critical to remain vigilant about the quality of medications reaching consumers. The recent recalls by Indian pharmaceutical companies highlight the ongoing challenges in manufacturing standards. While these recalls may cause temporary concerns, they also reflect the stringent oversight by the USFDA, ensuring patient safety remains paramount. We must continue advocating for transparency and quality within the industry.
NationPress
28/09/2025
Frequently Asked Questions
What caused the recent recalls by Indian pharmaceutical companies?
The recalls were initiated due to manufacturing issues, impurities, and labeling errors identified by the USFDA.
What is a Class II recall?
A Class II recall indicates that the use of a product may cause temporary or reversible health issues, with the risk of serious problems being low.
How many tubes of Azelaic Acid Gel is Glenmark recalling?
Glenmark is recalling 13,824 tubes of Azelaic Acid Gel due to complaints regarding its gritty texture.
What are Class III recalls?
Class III recalls are issued for products that are unlikely to cause harm.
Why is Unichem Pharmaceuticals recalling its product?
Unichem is recalling its product due to a labeling mix-up, which is classified as a Class I recall, the most serious category.
