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Class II · ModerateActive recall

Phytonadione

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCipla USA Inc.
Brand namePHYTONADIONE
Generic namePHYTONADIONE
Active ingredient(s)PHYTONADIONE
Distributed by / forCipla Limited
NDC69097-708-31
Show the full FDA record
Full product labelPhytonadione 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
Recalling firmCipla Limited
DistributionNationwide in the USA
Quantity4,438 10x1mL cartons
Recall initiated2025-10-31
Report date2025-12-10
Recall completed—
Recall numberD-0197-2026
ClassificationClass II
FDA statusOngoing
Origin on filePithampur, District Dhar India

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.