New Delhi, Jan 26: Indian pharmaceutical majors Sun Pharmaceutical Industries and Cipla have recalled certain products from the US market due to manufacturing-related issues, according to the latest Enforcement Report released by the US Food and Drug Administration (USFDA).
The US health regulator stated that the US-based arm of Mumbai-headquartered Sun Pharma has initiated a recall of more than 26,000 bottles of a generic medicine used to treat dandruff and inflammatory skin conditions. Sun Pharmaceutical Industries Inc, based in Princeton, New Jersey, is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution after the product failed to meet impurity and degradation specifications.
The recall was initiated on December 30, 2025, and has been classified as a nationwide Class III recall. According to the USFDA, a Class III recall is issued when the use of a product is unlikely to cause any adverse health consequences.
In addition, Sun Pharma is also recalling specific batches of Clindamycin Phosphate USP, a commonly prescribed medication for the treatment of acne vulgaris. This recall was initiated on November 26, 2025, after laboratory tests revealed impurity levels and assay values outside the acceptable limits. The USFDA has similarly categorised this action as a Class III recall.
Separately, the USFDA reported that Cipla’s US subsidiary has recalled over 15,000 syringes from the American market. Cipla USA Inc, headquartered in Warren, New Jersey, is recalling 15,221 pre-filled syringes of Lanreotide Injection due to the presence of particulate matter in the product.
Cipla initiated a nationwide Class II recall on January 2, 2026. The USFDA explained that a Class II recall applies to products that may cause temporary or medically reversible health effects, although the likelihood of serious harm is considered remote.
The US continues to be the world’s largest pharmaceutical market, making strict regulatory compliance and adherence to quality standards critical for global drug manufacturers operating in the country.
