Mephyton Phytonadione 5 mg Tablets Recall for Failed Impurity Specifications
Bausch Health Companies is recalling Mephyton (Phytonadione) 5 mg tablets nationwide because certain lots failed impurities and degradation specifications. Affected consumers should contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a labeling or manufacturing issue (failed impurities/degradation specifications) with no reported illnesses or injuries stated in the source. Class III recalls are typically scored 1 or 2; a manufacturing specification failure warrants the higher end of this range.
Plain-English summary
Bausch Health Companies, Inc. is recalling Mephyton (Phytonadione) 5 mg tablets, 100-count bottles, due to failed impurities and degradation specifications. The affected product is manufactured for Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ.
The recall affects 2,691 bottles distributed nationwide within the United States. Two lots are involved: Lot #19D012P (Expiration Date 07/2021) and Lot #20D096P (Expiration Date 10/2022). The product National Drug Code (NDC) number is 0187-1704-05.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Do not use the recalled product without consulting a healthcare professional about next steps.
The recalled product
- Product
- Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
- Manufacturer
- Bausch Health Companies, Inc.
- Category
- Drug — Prescription Tablet
- Affected units
- 2,691
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 19D012P
- Exp Date 07/2021
- 20D096P
- Exp Date 10/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bausch Health Companies, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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