Warning
Cipla Limited Recalls Phytonadione Injectable Emulsion
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0197-2026Drug / Pharmaceutical
Cipla Limited Recalls Phytonadione Injectable Emulsion
Cipla Limited · Class II — Moderate Risk
Product Description
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
Reason for Recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Cipla Limited has recalled a pharmaceutical product that the FDA classified as Class II affecting 4,438 10x1mL cartons. The recall was initiated on October 31, 2025. Failed Stability Specifications: Observed OOS results: eg results for colour index. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.