CLASS III Drug recall · Reported 3 Feb 2021 · FDA Enforcement Report
Phytonadione Tablets 5mg recalled by Bausch Health Companies
Bausch Health Companies is recalling Phytonadione Tablets 5mg, distributed nationwide in the US. The recall was initiated on 7 Jan 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-0244-2021
- FDA event ID
- 87093
- Recalling firm
- Bausch Health Companies, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jan 2021
- FDA classified
- 25 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Jan 2021 | Recall initiated by company | |
| 25 Jan 2021 | Classified by FDA | +18 days |
| 3 Feb 2021 | Published in enforcement report | +9 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:Out of specification during the 24 month stability testing of Impurity D.
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
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Which lots are affected?
Lot: 18L091P, Exp 05/2021
Where was it sold?
Distributed Nationwide in the USA
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 87093| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Mephyton (phytonadione) Tablets 5mg 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 recalled | 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) 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 II | Hydrocortisone butyrate Cream, 0.1% tubes recalled | Bausch Health Companies | Potency & Assay | Nationwide |
Other Phytonadione recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione | Cipla | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Injectable Emulsion USP, 10 mg/mL recalledPhytonadione | Dr. Reddy's Laboratories | 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 | Phytonadione Tablets 5 mg recalled by AVKARE | Avkare | Potency & Assay | CA |
| Drug | CLASS I | Phytonadione Injectable Emulsion, USP, 10 mg/mL ampule recalledPhytonadione | Dr. Reddy's Laboratories | Packaging Defects | Nationwide |