Indian drugmakers recall medicines in US over manufacturing issues

Indian pharmaceutical companies Sun Pharmaceutical Industries and Cipla have recalled certain products from the United States market due to manufacturing related issues, according to the latest Enforcement Report released by the US Food and Drug Administration.

The US based arm of Mumbai headquartered Sun Pharmaceutical Industries is recalling more than 26,000 bottles of a generic medicine used to treat dandruff and inflammatory skin conditions. Sun Pharmaceutical Industries Inc, headquartered in Princeton, New Jersey, recalled 24,624 bottles of Fluocinolone Acetonide Topical Solution after the product failed to meet impurity and degradation standards.

The company initiated a nationwide Class III recall on December 30, 2025. The USFDA said a Class III recall applies to products that are not likely to cause adverse health consequences.

In a separate action, Sun Pharma is also recalling certain batches of Clindamycin Phosphate USP, a drug commonly prescribed for acne vulgaris. This recall was initiated on November 26, 2025, after testing showed impurity levels and assay values outside acceptable limits. The USFDA has also classified this as a Class III recall.

Meanwhile, Cipla’s US subsidiary has recalled over 15,000 syringes from the American market. Cipla USA Inc, based in Warren, New Jersey, is recalling 15,221 pre filled syringes of Lanreotide Injection due to the presence of particulate matter.

Cipla initiated a nationwide Class II recall on January 2, 2026. According to the USFDA, a Class II recall is issued when the use of a product may cause temporary or medically reversible health effects, though the likelihood of serious harm is low.

The United States is the world’s largest pharmaceutical market, making adherence to regulatory standards and manufacturing quality critical for drugmakers operating in the country.