CLASS III Drug recall · Reported 30 Jun 2021 · FDA Enforcement Report
Mephyton (Phytonadione) recalled by Bausch Health Companies
Bausch Health Companies is recalling Mephyton (Phytonadione), distributed nationwide in the US. The recall was initiated on 8 Jun 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0638-2021
- FDA event ID
- 88079
- Recalling firm
- Bausch Health Companies, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Jun 2021
- FDA classified
- 23 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 8 Jun 2021 | Recall initiated by company | |
| 23 Jun 2021 | Classified by FDA | +15 days |
| 30 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88079| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
More recalls from Bausch Health Companies
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omeprazole and Sodium Bicarbonate For Oral Suspension recalledOmeprazole And Sodium Bicarbonate | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Mephyton (phytonadione) Tablets 5mg recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Tablets 5mg recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone butyrate Cream, 0.1% tubes recalled | Bausch Health Companies | Potency & Assay | Nationwide |