The US Food and Drug Administration (USFDA) has announced that a number of Indian pharmaceutical companies, including Sun Pharma, Zydus, Unichem, Granules India, and Glenmark, are recalling medications that are available in the US market.

According to the regulator’s most recent Enforcement Report, the recalls are connected to production problems, contaminants, and labeling errors.

13,824 tubes of Azelaic Acid Gel made at Glenmark Pharmaceuticals’ Goa facility are being recalled because of complaints about their gritty feel.

On September 17, the US division of the corporation began a Class II countrywide recall. These recalls occur when a product’s use may result in transient or reversible health problems, even while there is little chance of more serious issues.

In addition, more than 49,000 bottles of a combination medication for attention deficit hyperactivity disorder (ADHD) are being recalled by Granules India.

After the product failed tests for impurities and deterioration, its US branch started the recall on August 28.

Since this is a Class III recall, there is little chance that the product will be harmful.

1,870 kits of a renal imaging agent were recalled by Sun Pharma’s US affiliate after dissolving tests were unsuccessful. On September 3, this Class II recall was made public.

Similarly, 8,784 bottles of the antiviral medication Entecavir tablets are being recalled by Zydus Pharmaceuticals (USA) Inc., a division of Ahmedabad-based Zydus, because of impurity and degradation issues.

On September 4, the recall—which is also categorized as Class II—began. A Class I recall has been issued by Unichem Pharmaceuticals USA Inc. for 230 medication bottles due to a label mix-up.

The recall was initiated on August 27 by the East Brunswick-based corporation. A Class I recall is regarded as the most serious since patients who take the incorrect medication may face substantial health concerns.

On the other hand, India has the most USFDA-approved pharmaceutical plants outside of the US.