Phytonadione Injection, Emulsion
FDA Recall NDC 69097-708
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Phytonadione (NDC 69097-708). A significant event, classified as Class II, was initiated on Oct 31, 2025 by Cipla Usa Inc.. The reported reason for this action was: "Failed Stability Specifications: Observed OOS results: eg results for colour index"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Stability Specifications: Observed OOS results: eg results for colour index
Oct 31, 2025
Dec 10, 2025
4,438 10x1mL cartons
Recall Profile & Regulatory Data
Event ID
97909
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Batch# PH0072404A, PH0082404A, Exp. Date December 31, 2025
Affected Packages Involved in this Recall
69097-709-96Product
69097-708-96Product
69097-708-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
