Bausch Health recalls Phytonadione tablets due to impurity risks
Bausch Health recalls 5mg Phytonadione tablets with potential impurity issues from stability testing. Affected lots may pose risks if used improperly.
Recall notice
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Contact the company
What happened, in plain English
Baus: Health is recalling 5mg Phytonadione tablets that failed stability testing for impurity D. This could mean the tablets might have harmful substances that could cause health issues if taken. Read more at govinfonow.com/recall/36554-bausch-health-recalls-phytonadione-tablets-due-to-impurity-risks.
Source Summary by GovInfoNow · govinfonow.com/recall/36554-bausch-health-recalls-phytonadione-tablets-due-to-impurity-risks · Updated October 4, 2026 · FDA enforcement record: FDA #D-0244-2021
Cite this page
“Bausch Health recalls Phytonadione tablets due to impurity risks.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36554-bausch-health-recalls-phytonadione-tablets-due-to-impurity-risks. Based on FDA recall #D-0244-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0244-2021%22&limit=1).
Why it’s dangerous
The tablets failed stability testing for impurity D, which means they might contain harmful substances that could cause health problems. This issue was found during the 24-month testing period, indicating potential risks if the tablets are used as intended.
Who’s affected
People who have the 5mg Phytonadione tablets with lot number 18L091P from the manufacturer Oceanside Pharmaceuticals are affected. Those taking the medication for vitamin K deficiency are most at risk.
How to tell if you have this one
Check for the 5mg Phytonadione tablets with lot number 18L091P, manufactured by Oceanside Pharmaceuticals. The product was sold with an expiration date of May 2021.
- Brand
Bausch Health- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Distributed Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0243-2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05; Lot: 18L092P, Exp 05/2021 | 895 bottles |
| D-0244-2021 | 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; Lot: 18L091P, Exp 05/2021 | 14,089 bottles |
What to do — step by step
Check Product Details
Look for the lot number 18L091P on the tablet packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0244-2021 (January 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0244-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.