Cipla Limited

FDA Regulatory Profile

Cipla Limited appears in FDA public data with 3 recalls, 0 510(k) clearances, 35 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0197-2026, Class II) was initiated on October 31, 2025.

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