Midazolam in 0 — Class I drug recall D-0117-2024
Ongoing recall by Exela Pharma Sciences LLC, reported 2023-11-29, distributed nationwide. Presence of Particulate Matter: Silicone
| Recall number | D-0117-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2023-10-18 |
| Classified | 2023-11-22 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 23,425 vials |
| Reason classes | specification failure |
| NDC | 51754-2131-01, 51754-2131-04 |
| Lot numbers | 10001088 |
| Expiration dates | 2024-07-31 |
Product
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).
Reason for recall
Presence of Particulate Matter: Silicone
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-0117-2024. 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.