FDA recall D-0197-2026

Product

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-10-31

Report date

2025-12-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pithampur, District Dhar, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0197-2026