FDA Drug recall D-0638-2021
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater…
- FDA Drug
- Class III
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class III recall of Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater… by Bausch Health Companies, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0638-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-06-08 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bausch Health Companies |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0638-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.