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.
What this means for you
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
- Hazard
- impurity-contamination
- degradation-failure
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.
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