Fluorouracil Injection — Class I drug recall D-1489-2019
Terminated recall by Fresenius Kabi USA, LLC, reported 2019-07-24, distributed nationwide. Presence of Particulate Matter; glass particulates
| Recall number | D-1489-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Melrose Park, IL, United States |
| Recall initiated | 2019-06-28 |
| Classified | 2019-07-17 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2022-09-20 |
| Distributed | Nationwide (US) |
| Quantity | 14,016 vials |
| Reason classes | foreign material, specification failure |
| NDC | 63323-0117, 63323-0117-51, 63323-0117-59, 63323-0117-61, 63323-0117-69 |
| Lot numbers | 6120341, 6120420 |
Product
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Reason for recall
Presence of Particulate Matter; glass particulates
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-1489-2019. 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.