phytonadionedrugHigh PriorityActive

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

phytonadione 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 recalled by FDA. Failed Stability Specifications: Observed OOS results: eg results for colour index

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: October 31, 2025
Last reviewed by RecallRadar: March 4, 2026

What You Should Do

1## 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
2Vial NDC# 69097-708-31; Carton NDC 69097-708-96 Agency: FDA | Category: drug Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index What to do:
3Stop using the product if your lot/model matches.
4Check the FDA notice for specifics.

Open Official Recall Notice Get Alerts for phytonadione Devices

What's Being Recalled

Quoted source excerpt from the official notice.

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

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025

#	Model
1	Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my phytonadione device affected?

Check the affected models section on this page. The official notice currently lists Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025.

What is the remedy for this recall?

## 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 Agency: FDA | Category: drug Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: phytonadione recall hub and Food & Drug recall hub.