Drug recall
Phytonadione Injectable Emulsion, USP 1mg/0.5 mL, 10 x 0.5 ml Single-Dose Prefilled Syringes, For Intravenous…
FDA recall event 99763 · Class III · Amneal Pharmaceuticals of New York, LLC
Key facts
| Event ID | 99763 |
|---|---|
| Recall numbers | D-0011-2027 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Aug 28, 2026 |
| Report date | Sep 23, 2026 |
| City | Brookhaven |
| State | NY |
| Country | United States |
| FEI number | 3005263655 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: