Indian drug majors Sun Pharmaceutical Industries and Cipla have recalled multiple pharmaceutical products from the United States market following manufacturing and quality-related issues, according to the latest Enforcement Report issued by the US Food and Drug Administration (USFDA).

The US-based arm of Mumbai-headquartered Sun Pharma has recalled more than 26,000 bottles of a generic topical medicine used for treating dandruff and inflammatory skin conditions. Sun Pharmaceutical Industries Inc, based in Princeton, New Jersey, has recalled 24,624 bottles of Fluocinolone Acetonide Topical Solution after the product failed to meet impurity and degradation specifications. The company initiated a Class III nationwide recall across the US on December 30, 2025.

In addition, Sun Pharma is also recalling specific batches of Clindamycin Phosphate USP, a medication used in the treatment of acne vulgaris. The recall, initiated on November 26, 2025, was also classified as Class III, following out-of-specification results related to total impurities and assay standards. According to the USFDA, Class III recalls involve products that are unlikely to cause adverse health consequences, even if used.

In a separate action, Cipla’s US subsidiary has also announced a recall in the American market. Cipla USA Inc, headquartered in Warren, New Jersey, is recalling 15,221 pre-filled syringes of Lanreotide Injection (120 mg/0.5 mL) due to the presence of particulate matter. This recall was initiated on January 2, 2026, and has been classified as a Class II recall.

The USFDA defines a Class II recall as one where product use may lead to temporary or medically reversible health consequences, with a minimal risk of serious harm.