Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/
Recalled December 10, 2025 · FDA recall D-0197-2026 · Cipla
Hazard
Failed Stability Specifications: Observed OOS results: eg results for colour index · FDA Class II
Units
4,438 10x1mL cartons
Sold at
Nationwide in the USA
Description
Failed Stability Specifications: Observed OOS results: eg results for colour index
Product
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
Manufacturer(s)
Cipla Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →