Fosphenytoin Sodium Injection — Class II drug recall D-0076-2018
Terminated recall by Amneal Pharmaceuticals LLC, reported 2017-11-22, distributed in MS, NC, OH, TX, UT. Presence of Particulate Matter
| Recall number | D-0076-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals LLC, Glasgow, KY, United States |
| Recall initiated | 2017-08-31 |
| Classified | 2017-11-13 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2019-09-10 |
| Distributed | MS, NC, OH, TX, UT |
| Quantity | 14,000 vials |
| Reason classes | specification failure |
| NDC | 70121-1390-07 |
| Lot numbers | 05/18, AP160016 |
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Reason for recall
Presence of Particulate Matter
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-0076-2018. 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.