Midazolam Injection — Class I drug recall D-0152-2018
Terminated recall by Fresenius Kabi USA, LLC, reported 2018-01-10, distributed nationwide. Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringe
| Recall number | D-0152-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Wilson, NC, United States |
| Recall initiated | 2017-10-27 |
| Classified | 2018-01-04 |
| Reported by FDA | 2018-01-10 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 203,136 syringes |
| Reason classes | labeling |
| NDC | 76045-0001, 76045-0001-00, 76045-0001-20, 76045-0002, 76045-0002-00, 76045-0002-10, 76045-0003, 76045-0003-00, 76045-0003-20, 76045-0211, 76045-0211-00, 76045-0211-20 |
| Lot numbers | 6400048 |
Product
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
Reason for recall
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
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-0152-2018. 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.