Ondansetron Injection — Class III drug recall D-1386-2019
Terminated recall by Fresenius Kabi USA, LLC, reported 2019-06-19, distributed nationwide. Failed Impurities/Degradation Specifications.
| Recall number | D-1386-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Grand Island, NY, United States |
| Recall initiated | 2019-05-22 |
| Classified | 2019-06-14 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2021-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 11,981 units |
| Reason classes | specification failure |
| NDC | 63323-0373, 63323-0373-00, 63323-0373-02, 63323-0374, 63323-0374-20 |
| Lot numbers | 6018699 |
| Expiration dates | 2021-12 |
Product
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Reason for recall
Failed Impurities/Degradation Specifications.
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-1386-2019. 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.