Drug FDA Class II Ongoing Failed specifications

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

Cipla Limited Published Dec 10, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Cipla Limited or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Failed Stability Specifications - Colour Index · primary

Affected products (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 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96

PHYTONADIONE · 4,438 10x1mL cartons

NDC: 69097-708, 69097-709, 69097-709-96, 69097-708-96, 69097-708-31

Code info: Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025

Affected areas

Nationwide

Timeline

Initiated

Oct 31, 2025
Published

Dec 10, 2025

Recall number: D-0197-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.