Bausch Health recalls Mephyton 5mg tablets due to impurities risk
Baus: Health recalls Mephyton 5mg tablets (NDC 0187-1704-05) manufactured for Valeant. Failed impurities could cause harm. Check lot numbers 19D012P (exp 07/2021) or 20D096P (exp 10/2022).
“Bausch Health recalls Mephyton 5mg tablets due to impurities risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36125-bausch-health-recalls-mephyton-5mg-tablets-due-to-impurities-risk. Based on FDA recall #D-0638-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0638-2021%22&limit=1).
The FDA announced on June 8, 2021, that Bausch Health Companies, Inc. is recalling Mephyton (Phytonadione) 5 mg tablets due to failed impurities and degradation specifications. The recall affects 2,691 bottles distributed nationwide.
How to tell if you have it
Mephyton (Phytonadione) 5 mg tablets
100-count bottles
NDC 0187-1704-05
Lot #19D012P, Exp Date 07/2021
Lot #20D096P, Exp Date 10/2022
The hazard
The tablets failed impurities and degradation specifications. The recall is classified as Class III.
Context
GovInfoNow's records show Bausch Health Companies, Inc. has had three other recalls since July 13, 2020, including a February 2, 2024, omeprazole suspension recall for subpotent drug risk and a January 7, 2021, Mephyton recall for impurity risks. Other recent recalls of similar products include Macleods Olanzapine Tablets 5mg Recall (August 27, 2026), Sagent Busulfan Injection Recall (May 4, 2026), and Sun Pharmaceutical Fexofenadine 180mg Tablets Recall (June 1, 2026).
How to tell if you have this one
Check the lot number on the tablet packaging: 19D012P (expires 07/2021) or 20D096P (expires 10/2022). The product is prescription-only and sold under NDC 0187-1704-05.
Brand
Bausch Health
Category
Drug
FDA recall event · 2 products
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
Nationwide within the United States
Recall number
Product, codes & lots
Quantity
D-0638-2021
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.; Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
2,691 bottles
D-0639-2021
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; Lot #:19D013P, Exp Date 07/2021; 20D099P, Exp Date 10/2022
37,797 bottles
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for lot numbers 19D012P or 20D096P on the tablet packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0638-2021 (June 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0638-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.