Phytonadione Tablets 5mg — Class III drug recall D-0244-2021
Terminated recall by Bausch Health Companies, Inc., reported 2021-02-03, distributed nationwide. Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Imp
| Recall number | D-0244-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch Health Companies, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2021-01-07 |
| Classified | 2021-01-25 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2022-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 14,089 bottles |
| Reason classes | specification failure |
| NDC | 68682-0170-30 |
| Lot numbers | 18L091P |
| Expiration dates | 2021-05 |
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
Reason for recall
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
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-0244-2021. 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.