Bausch Health Recalls Mephyton Tablets Due to Impurity D Failure
Bausch Health is recalling 895 bottles of Mephyton (phytonadione) 5mg tablets because Impurity D failed stability testing specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Bausch Health Companies, Inc. is recalling 895 bottles of Mephyton (phytonadione) Tablets 5mg, 100-count bottles. The product is prescription-only and was distributed nationwide in the USA. The specific lot affected is 18L092P, with an expiration date of 05/2021.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, Impurity D was found to be out of specification during 24-month stability testing. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should discontinue use of the affected lot and return the product to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Mephyton (phytonadione) Tablets 5mg, 100-count bottle, 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 Medication
- Hazard
- Affected units
- 895
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 (2)
- Lot: 18L092P
- Exp 05/2021
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Bausch Health Companies, Inc.
See all →- HighOmeprazole and Sodium Bicarbonate Prescription Drug Recalled Due to Subpotency
FDA (Drugs) · 2024-03-06
- ModerateMephyton Phytonadione 5 mg Tablets Recall for Failed Impurity Specifications
FDA (Drugs) · 2021-06-30
- LowPhytonadione 5 mg Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2021-06-30
- LowBausch Health Recalls Phytonadione Tablets Due to Impurity D
FDA (Drugs) · 2021-02-03
- SevereBausch Health Recalls Subpotent Hydrocortisone Butyrate Cream
FDA (Drugs) · 2020-11-04
Same hazard · impurity failure
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateDigoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications
FDA (Drugs) · 2024-04-24
- HighPrescription Rifampin Capsules Recalled Due to Failed Quality Specifications
FDA (Drugs) · 2023-01-25
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- ModerateAurolife Pharma Recalls Fexofenadine Hydrochloride Tablets for Impurity Failures
FDA (Drugs) · 2019-09-25