Phytonadione Injectable Emulsion, USP 10mg/mL
Recalled by Cipla Limited
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Cipla Limited has recalled Phytonadione Injectable Emulsion, USP 10mg/mL, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 10, 2025 and was initiated on October 31, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Phytonadione Injectable Emulsion, USP 10mg/mL, with approximately 4,438 10x1mL cartons affected. The company behind the recall is Cipla Limited, based in Pithampur, District Dhar. The FDA describes the product as: “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”
Why was Phytonadione Injectable Emulsion, USP 10mg/mL recalled?
According to the FDA, the stated reason for the recall is: “Failed Stability Specifications: Observed OOS results: eg results for colour index.”
What should you do?
If you think you may have bought Phytonadione Injectable Emulsion, USP 10mg/mL, compare it against the product description and identifying codes (Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Cipla Limited or your local health authority.
About this recall
This recall was distributed in Nationwide in the USA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- December 10, 2025
- Recall started
- October 31, 2025
- Distributed in
- Nationwide in the USA
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Phytonadione Injectable Emulsion, USP 10mg/mL recalled?+
According to the FDA: Failed Stability Specifications: Observed OOS results: eg results for colour index
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Phytonadione Injectable Emulsion, USP 10mg/mL?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0197-2026. Information last synced from the FDA on July 5, 2026.