Mephyton — Class III drug recall D-0638-2021
Terminated recall by Bausch Health Companies, Inc., reported 2021-06-30, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0638-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch Health Companies, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2021-06-08 |
| Classified | 2021-06-23 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2023-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,691 bottles |
| Reason classes | specification failure |
| NDC | 00187-1704-05 |
| Lot numbers | 19D012P, 20D096P |
| Expiration dates | 2021-07, 2022-10 |
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0638-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.