Cipla Limited

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
35
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0197-2026Class IIPhytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: CiOctober 31, 2025
D-0382-2019Class IINevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. VDecember 14, 2018
D-1078-2015Class IIILevalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla LtApril 24, 2015