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All product recalls associated with SUN PHARMACEUTICAL INDUSTRIES INC.
Total Recalls
1000
Past Year
303
Class I (Serious)
34
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.