Indian pharmaceutical companies Sun Pharmaceutical Industries and Cipla have withdrawn certain medications from the US market due to manufacturing-related issues, according to the most recent information from the US Food and Drug Administration (USFDA).

According to the US health regulator’s Enforcement Report, the US-based branch of Mumbai-based Sun Pharma is recalling more than 26,000 bottles of a generic drug used to treat dandruff and skin conditions that cause irritation and itching.

Sun Pharmaceutical Industries Inc., located in Princeton, New Jersey, is recalling 24,624 vials of Fluocinolone Acetonide Topical Solution because the product does not meet impurity and degradation standards.

The company initiated a Class III recall nationwide on December 30, 2025. A Class III recall, according to the USFDA, occurs when there is minimal possibility that utilizing the product will have any detrimental effects on one’s health.

According to the EPA, Sun Pharma is also recalling certain batches of Clindamycin Phosphate USP, a drug used to treat acne vulgaris.

This recall was initiated on November 26, 2025, following test results that showed impurity levels and assay values were beyond of acceptable limits. This recall has also been classified as Class III.

According to a different USFDA report, a US-based division of Cipla has recalled over 15,000 syringes from the US market.

Cipla USA Inc., based in Warren, New Jersey, is recalling 15,221 pre-filled Lanreotide Injection syringes due to particulate matter.

Cipla initiated a nationwide Class II recall on January 2 of this year.

According to the USFDA, a Class II recall is made when a product’s use may have temporary or medically reversible health effects but there is little chance of major harm.

Drug manufacturers operating in the US must pay special attention to product quality and regulatory compliance because the US is still the world’s largest pharmaceutical market.