Sun Pharma, Cipla Recall Products In US Following Manufacturing Lapses

Indian pharmaceutical majors Sun Pharmaceutical Industries and Cipla have recalled certain medicines from the US market due to manufacturing-related deficiencies, according to the latest Enforcement Report issued by the US Food and Drug Administration (USFDA).

The US health regulator said Sun Pharmaceutical Industries Inc, 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 inflammatory skin conditions.

The Princeton, New Jersey-based unit is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution after the product failed to meet impurity and degradation specifications.

The company initiated a nationwide Class III recall on December 30, 2025. The USFDA noted that a Class III recall is issued in situations where the use of the product is not likely to cause any adverse health consequences.

In addition, the regulator said Sun Pharma is recalling certain batches of Clindamycin Phosphate USP, a medicine commonly prescribed for acne vulgaris. This recall was initiated on November 26, 2025, after test results showed impurity levels and assay values outside acceptable limits. The recall has also been classified as Class III.

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.

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, although the probability of serious harm is low.

The United States remains the world’s largest pharmaceutical market, underscoring the importance of strict regulatory compliance and product quality for drugmakers operating in the country.

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