Sun Pharma, Cipla recall medicines in US over manufacturing issues

Indian drugmakers Sun Pharmaceutical Industries and Cipla have recalled several products from the US market following manufacturing-related concerns, according to the latest Enforcement Report issued by the US Food and Drug Administration (USFDA).

The regulator said Sun Pharmaceutical Industries’ US arm has initiated a recall of more than 26,000 bottles of a generic medication 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 standards.

The nationwide recall was initiated on 30 December 2025, and has been classified as Class III. The USFDA noted that a Class III recall applies to products that are unlikely to cause adverse health effects.

In a separate action, Sun Pharma is also recalling certain batches of Clindamycin Phosphate USP, a drug used in the treatment of acne vulgaris. This recall was initiated on 26 November 2025, after tests showed impurity levels and assay values outside acceptable limits. It has also been classified as a Class III recall.

Meanwhile, Cipla’s US-based subsidiary has recalled more than 15,000 units 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 2 January 2026. The USFDA said Class II recalls are issued when the use of a product may cause temporary or medically reversible health effects, though the likelihood of serious harm is low.

The recalls underscore the importance of stringent quality controls and regulatory compliance in the US, the world’s largest pharmaceutical market, where manufacturing standards are closely scrutinised.

With IANS inputs