Amneal Phytonadione Injectable Emulsion
Phytonadione Injectable Emulsion failed impurities and degradation specifications.
What happened
Amneal Pharmaceuticals of New York, LLC began a recall of Phytonadione Injectable Emulsion, USP 1mg/0.5 mL, 10 x 0.5 ml Single-Dose Prefilled Syringes on August 28, 2026, because the product failed impurities and degradation specifications. The recall involved 8,201 cartons and was added to the FDA's Enforcement Report on September 15, 2026, with classification on October 6, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the lot code and NDC listed under your product.
Phytonadione Injectable Emulsion, USP
- Strength
- 1 mg
- Lot
- AP250506
- AP250521
- AP250522
- NDC
- 70121-1682-7
- 70121-1682-1
Details
- Company began the recall
- Event ID
- 99763
- Company
- Amneal Pharmaceuticals of New York, LLC
- Hazard
- Impurity or degradation
- Quantity recalled
- 8,201 cartons
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
