Reported Sep 23, 2026 · Ongoing

Phytonadione Injectable Emulsion, USP 1mg/0.5 mL, 10 x 0.5 ml Single-Dose Prefilled Syringes, For Intravenous,…

Amneal Pharmaceuticals of New York, LLC

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

Is this the product you have?

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

3 of 3 products

Products covered by this recall
#Product as published
1Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India
2Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC Carton: 70121-1682-7
3NDC Tray: 70121-1682-1
Lot codes and dates
  • Batch
  • expiry
    • Batch AP250506
    • exp 04/2027
    • Batches AP250521
    • AP250522
    • exp 05/2027
Amount recalled
8,201 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

The agency has not ranked the risk yet — treat the notice as a caution.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 2:15 PM UTC

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