Phytonadione recalls

The FDA has published 8 recalls involving Phytonadione since 2014. The latest was reported on 10 Dec 2025. Most were for potency & assay. Aidapak Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2014

Last 12 months1reported

Class I113% of total

Ongoing1latest 10 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 13%Class II 3 38%Class III 4 50%

Why phytonadione is recalled

Companies

By year

2025113%
2022113%
2021338%
2020113%
2014225%

Ongoing phytonadione recalls

1 active

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione	Cipla	Potency & Assay	Nationwide

All phytonadione recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione	Cipla	Potency & Assay	Nationwide
12 Oct 2022Drug	CLASS III	Phytonadione Injectable Emulsion USP, 10 mg/mL recalledPhytonadione	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
30 Jun 2021Drug	CLASS III	Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
23 Jun 2021Drug	CLASS III	Phytonadione Tablets 5 mg recalled by AVKARE	AVKARE	Potency & Assay	CA
3 Feb 2021Drug	CLASS III	Phytonadione Tablets 5mg recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
8 Apr 2020Drug	CLASS I	Phytonadione Injectable Emulsion, USP, 10 mg/mL ampule recalledPhytonadione	Dr. Reddy's Laboratories	Packaging Defects	Nationwide
22 Jan 2014Drug	CLASS II	Phytonadione Tablet, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Phytonadione Tablet, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Phytonadione?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.