Sun Pharma, Cipla Recall Products In US: FDA

Sun Pharmaceutical Industries Ltd and Cipla Ltd are recalling products in the United States due to manufacturing-related issues, according to the US Food and Drug Administration.

The US-based arm of the Mumbai-based pharma major is recalling over 26,000 bottles of a generic medication to treat dandruff and skin conditions with inflammation and itching, the FDA said in its latest enforcement report.

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 Dec. 30, 2025.

The FDA said the company was also recalling certain batches of a medication to treat acne vulgaris. Sun Pharma Inc initiated the Class III recall of Clindamycin Phosphate USP on Nov. 26, 2025, due to ‘Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay’, it added.

As per the FDA, 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, the FDA stated that a US-based arm of Mumbai-headquartered drug maker Cipla is recalling 15,221 syringes in the US market.

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 FDA noted. The company initiated the Class II nationwide recall on Jan. 2 this year.

As per the FDA, 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.

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