Fosphenytoin Sodium Injection — Class II drug recall D-0610-2018
Terminated recall by Amneal Pharmaceuticals, reported 2018-04-04, distributed nationwide. Presence of particulate matter
| Recall number | D-0610-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, Brookhaven, NY, United States |
| Recall initiated | 2017-12-15 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 12,584 vials |
| Reason classes | specification failure |
| NDC | 70121-1390-01 |
| Lot numbers | AP160022, AP160023, AP160039, AP160040, AP160076, AP160077, AP160078, AP16038 |
| Expiration dates | 2018-05, 2018-06, 2018-12 |
Product
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
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-0610-2018. 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.