Archive · 28 Sep 2025
Indian Drugmakers Glenmark, Granules, Zydus Recall Products in US
Several Indian drug companies, including Glenmark, Granules India, Sun Pharma, Zydus, and Unichem, are recalling their products in the US.
These recalls are due to various issues like gritty texture in some products, failed quality tests, or a label mix-up.
The US Food and Drug Administration (FDA) is overseeing these recalls.
The recalls are classified into different categories, ranging from those that may cause temporary health issues to those unlikely to cause harm.
Glenmark, Granules, Zydus, Sun Pharma, and Unichem are recalling products in the US market.
Recalls are due to manufacturing issues, failed specifications, and label errors.
Glenmark is recalling Azelaic Acid Gel due to gritty texture.
Granules is recalling extended-release capsules for failing impurity tests.
Sun Pharma is recalling renal imaging agent kits due to failed dissolution specifications.
- Who
- Glenmark, Granules India, Sun Pharma, Zydus, Unichem
- What
- Recalling products in the US due to manufacturing issues.
- When
- Recalls initiated between August 27 and September 17.
- Where
- US market
- Why
- Manufacturing deviations, failed specifications, and label mix-ups.
- Companies Recalling
- Glenmark, Granules India, Sun Pharma, Zydus, Unichem
- Reason for Recalls
- Manufacturing issues, failed specifications, label mix-up
- Regulatory Body
- US Food and Drug Administration (USFDA)
- Recall Classifications
- Class II (potential temporary health issues), Class III (unlikely adverse effects), Class I (label mix-up)
- Glenmark Product
- Azelaic Acid Gel
- Granules India Product
- Dextroamphetamine/Amphetamine capsules
- Sun Pharma Product
- Renal imaging agent kits
- Zydus Product
- Entecavir tablets
- Unichem Product
- Medication with label mix-up