Amneal Pharmaceuticals Of New York, Llc: Phytonadione Injectable Emulsion, Usp 1mg/0

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product
Phytonadione Injectable Emulsion, USP 1mg/0.5 mL, 10 x 0.5 ml Single-Dose Prefilled Syringes, For Intravenous, Intramuscular or Subcutaneous Use, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC Carton: 70121-1682-7; NDC Tray: 70121-1682-1
Reason
Failed Impurities/Degradation Specifications
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-08-28
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
U.S. Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/4181faf6-d7df-4c78-9f67-020e2966ed91