Sun Pharma and Cipla Initiate US Recalls Over Quality Concerns
Indian drug giants recall products due to impurities and particulates.
Two leading Indian pharmaceutical companies, Sun Pharmaceutical Industries and Cipla, have announced voluntary recalls of specific products in the United States market following issues flagged by the US Food and Drug Administration. These actions highlight ongoing quality control challenges in the global supply chain for generic medicines, where the US remains the world’s largest pharmaceutical market.
Sun Pharma’s US arm, Sun Pharmaceutical Industries Inc., is recalling 24,624 bottles of fluocinolone acetonide topical solution, a generic medication used to treat dandruff and inflammatory skin conditions with itching. The Class III recall, initiated on December 30, 2025, stems from failed impurities and degradation specifications. The FDA classifies Class III recalls as situations where use of the product is unlikely to cause adverse health effects. Separately, Sun Pharma also recalled certain batches of clindamycin phosphate, an acne vulgaris treatment, starting November 26, 2025, due to out-of-specification results for total impurities and assay values—again under Class III.
In a more serious development, Cipla USA, Inc. is recalling 15,221 pre-filled syringes of Lanreotide Injection (120 mg/0.5 mL), a medication commonly used for certain endocrine tumors and acromegaly. This Class II recall, launched on January 2, 2026, was triggered by the presence of particulate matter in the product. According to FDA guidelines, Class II recalls apply when exposure may cause temporary or medically reversible health consequences, or where the probability of serious adverse outcomes remains low but cannot be ruled out entirely.
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These recalls come at a time when Indian generics form a significant portion of the US market, making quality assurance critical for patient safety. Both companies have initiated nationwide recalls in the US, and the FDA has listed them in its latest enforcement reports. No widespread adverse events have been publicly reported in connection with these specific batches so far.
The incidents underscore the rigorous scrutiny applied by US regulators to imported pharmaceuticals. While Class III recalls typically carry minimal risk, the Class II action involving injectable medicine draws particular attention due to the higher potential impact of particulates in such formulations.
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