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All product recalls associated with Cipla USA, Inc..
Total Recalls
25
Past Year
8
Class I (Serious)
1
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.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Failed Stability Specifications: Observed OOS results: eg results for colour index
Failed stability specifications: Out of specification for hardness test
Failed stability specifications: Out of specification for hardness test
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Lack of Assurance of Sterility: environmental monitoring failure.
Lack of Assurance of Sterility
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Lack of Assurance of Sterility: Complaints received of defective container closure.
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
CGMP Deviations
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline