Sun Pharma, Cipla recall products in US over manufacturing issues: USFDA

New Delhi: Drugmakers Sun Pharma and Cipla are recalling products in the US due to manufacturing related issues, according to the US Food and Drug Administration.

As per its latest Enforcement Report, the US-based arm of Mumbai-based Sun Pharma is recalling over 26,000 bottles of a generic medication to treat dandruff and skin conditions with inflammation and itching.

The Princeton (New Jersey)-based Sun Pharmaceutical Industries Inc is recalling 24,624 bottles of Fluocinolone Acetonide Solution Topical Solution for "Failed Impurities/Degradation Specifications", the US health regulator said.


The company initiated the Class III nationwide (US) recall on December 30, 2025.

The US Food and Drug Administration (USFDA) noted that the company is also recalling certain batches of a medication to treat acne vulgaris.

Sun Pharmaceutical Industries Inc initiated the Class III recall of Clindamycin Phosphate USP on November 26, 2025 due to "Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay", it added.

As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

In a separate disclosure, USFDA stated that a US-based arm of Mumbai-headquartered drug maker Cipla is recalling 15,221 syringes in the US market.

The Warren (New Jersey)-based Cipla USA, Inc is recalling the Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringes due to the "presence of particulate matter", the USFDA noted.

The company initiated the Class II nationwide recall on January 2 this year.

As per the USFDA, a Class II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

The US is the world's largest market for pharmaceutical products.