Sun Pharma, Cipla Recall Medicines in US Over Manufacturing Defects

In its Enforcement Report, the US health regulator said the US-based arm of Mumbai-headquartered Sun Pharma is recalling more than 26,000 bottles of a generic medicine used to treat dandruff and skin conditions that cause inflammation and itching.

Sun Pharmaceutical Industries Inc, which is based in Princeton, New Jersey, is recalling 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 in the US on December 30, 2025. The USFDA said a Class III recall is issued in cases where the use of the product is not likely to cause any adverse health effects.

The regulator also said Sun Pharma is recalling certain batches of Clindamycin Phosphate USP, a medicine used to treat acne vulgaris.

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

Separately, the USFDA said a US-based arm of Cipla has recalled over 15,000 syringes from the American market.

Cipla USA Inc, which is headquartered 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 this year. 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 chances of serious harm are low.

The US remains the world's largest pharmaceutical market, making regulatory compliance and product quality especially important for drugmakers operating in the country.

- IANS