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Pharma Giants Recall US Drugs Over Quality Issues
26 Jan
Summary
- Sun Pharma recalls over 26,000 bottles of dandruff medication.
- Cipla recalls 15,221 syringes of Lanreotide Injection.
- Recalls stem from manufacturing issues like impurities and particulate matter.
Two major pharmaceutical companies, Sun Pharmaceutical Industries and Cipla Ltd, are currently recalling products in the United States due to manufacturing-related concerns. Sun Pharma's US-based division initiated a Class III nationwide recall on December 30, 2025, for 24,624 bottles of fluocinolone acetonide solution, citing failed impurity and degradation specifications. This recall is not expected to cause adverse health consequences.
Additionally, Sun Pharma initiated a Class III recall on November 26, 2025, for certain batches of Clindamycin Phosphate USP, used to treat acne vulgaris, due to out-of-specification results for total impurities and assay. In a separate action, Cipla USA, Inc. began a Class II nationwide recall on January 2, 2026, for 15,221 syringes of Lanreotide Injection, 120 mg/0.5 mL. This recall is due to the presence of particulate matter, which could lead to temporary or medically reversible health consequences.
The US remains the largest global market for pharmaceutical products, making these recalls significant events. Class II recalls are initiated when a product may cause temporary adverse health effects, while Class III recalls are for situations unlikely to cause adverse health consequences.
