The Recall Desk
LowFDA (Drugs)·D-0244-2021·Announced 2021-02-03

Bausch Health Recalls Phytonadione Tablets Due to Impurity D

Bausch Health is recalling Phytonadione Tablets 5mg because Impurity D exceeded specifications during stability testing. The recall covers 14,089 bottles distributed nationwide.

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 Phytonadione Tablets 5mg, 30-count bottles, manufactured for Oceanside Pharmaceuticals. The recall involves 14,089 bottles with Lot 18L091P and an expiration date of 05/2021. These prescription-only products were distributed nationwide in the USA.

The recall was initiated because the product failed impurities/degradation specifications. Specifically, Impurity D was found to be out of specification during 24-month stability testing. The FDA 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 stop using the affected bottles and return them 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
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
Manufacturer
Bausch Health Companies, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
14,089

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: 18L091P
  • 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.

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Same hazard · impurity degradation

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