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
| # | Product as published |
|---|---|
| 1 | Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India |
| 2 | Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC Carton: 70121-1682-7 |
| 3 | NDC Tray: 70121-1682-1 |
- Lot codes and dates
- Batch
- expiry
Batch AP250506exp 04/2027Batches AP250521AP250522exp 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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