Cipla USA, Inc.

13 FDA enforcement actions

13 Total Recalls

1 Class I

10 Class II

2 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 01/02/2026 drug

Presence of Particulate Matter.
Class III: Low Risk 12/22/2025 drug

Failed PH Specifications
Class II: Risk 11/14/2025 drug

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025 drug

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025 drug

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 10/24/2025 drug

Failed stability specifications: Out of specification for hardness test
Class II: Risk 10/24/2025 drug

Failed stability specifications: Out of specification for hardness test
Class III: Low Risk 07/24/2025 drug

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.
Class II: Risk 06/30/2025 drug

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II: Risk 10/23/2024 drug

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II: Risk 10/23/2024 drug

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II: Risk 03/26/2024 drug

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class I: Dangerous 06/27/2023 drug

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.