Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M…

Recall date

October 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0197-2026

FDA classification

Class II

Brand / firm

Cipla Limited

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Stability Specifications: Observed OOS results: eg results for colour index

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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