Class II · Moderate risk
Phytonadione Injectable Emulsion
Failed Stability Specifications: Observed OOS results: eg results for colour index
Is Phytonadione recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Phytonadione (15 total). Check the affected lots below.
Most common reason: Impurity / degradation (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phytonadione. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Phytonadione recalls on record
none so far in 2026; 15 on record, newest first
Class II · Moderate risk
VITAMIN K (Phytonadione)
Lack of sterility assurance
Class III · Low risk
Phytonadione Injectable Emulsion USP
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class III · Low risk
Phytonadione Tablets 5 mg
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class III · Low risk
Phytonadione Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Mephyton (Phytonadione)
Failed Impurities/Degradation Specifications
Class III · Low risk
Phytonadione Tablets 5mg
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class III · Low risk
Mephyton (phytonadione)
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class I · High risk
Phytonadione Injectable Emulsion
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Class II · Moderate risk
IV Cocktail #2
Lack of Assurance of Sterility
Class II · Moderate risk
Infuvite IV
Lack of Assurance of Sterility
Class II · Moderate risk
Phytonadione
Lack of Assurance of Sterility
Class II · Moderate risk
PHYTONADIONE Tablet
Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,
Class II · Moderate risk
PHYTONADIONE Tablet
Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,
Class II · Moderate risk
Vitamin K
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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