CLASS III Drug recall · Reported 30 Jun 2021 · FDA Enforcement Report

Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies

Bausch Health Companies is recalling Phytonadione Tablets, 5 mg ablets, 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

Lot, batch or date codesLot #:19D013P, Exp Date 07/2021; 20D099P, Exp Date 10/2022

Quantity recalled37,797 bottles

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-0639-2021
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

Phytonadione Tablets, 5 mg, 30-count ablets, 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

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications

Which lots are affected?

Lot #:19D013P, Exp Date 07/2021; 20D099P, 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

This product is part of a recall event; the main page for the event is Mephyton (Phytonadione) recalled by Bausch Health Companies.

Reported	Class	Recall	Company	Reason	Where
30 Jun 2021	CLASS III	Mephyton (Phytonadione) 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
6 Mar 2024Drug	CLASS II	Omeprazole and Sodium Bicarbonate For Oral Suspension recalledOmeprazole And Sodium Bicarbonate	Bausch Health Companies	Potency & Assay	Nationwide
30 Jun 2021Drug	CLASS III	Mephyton (Phytonadione) recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
3 Feb 2021Drug	CLASS III	Mephyton (phytonadione) Tablets 5mg recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
3 Feb 2021Drug	CLASS III	Phytonadione Tablets 5mg recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
4 Nov 2020Drug	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
10 Dec 2025Drug	CLASS II	Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione	Cipla	Potency & Assay	Nationwide
12 Oct 2022Drug	CLASS III	Phytonadione Injectable Emulsion USP, 10 mg/mL recalledPhytonadione	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Jun 2021Drug	CLASS III	Phytonadione Tablets 5 mg recalled by AVKARE	Avkare	Potency & Assay	CA
3 Feb 2021Drug	CLASS III	Phytonadione Tablets 5mg recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
8 Apr 2020Drug	CLASS I	Phytonadione Injectable Emulsion, USP, 10 mg/mL ampule recalledPhytonadione	Dr. Reddy's Laboratories	Packaging Defects	Nationwide