CLASS I ONGOING Drug recall · Reported 29 Nov 2023 · FDA Enforcement Report
Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled
Exela Pharma Sciences is recalling Midazolam in 0.8% Sodium Chloride Injection 100 mg/ (1mg/mL) Single-Dose Vial, Ready to, distributed nationwide in the US. The recall was initiated on 18 Oct 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0117-2024
- FDA event ID
- 93265
- Recalling firm
- Exela Pharma Sciences, Lenoir, NC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 18 Oct 2023
- FDA classified
- 22 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Oct 2023 | Recall initiated by company | |
| 22 Nov 2023 | Classified by FDA | +35 days |
| 29 Nov 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Silicone
Product as listed by the FDA
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).
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Silicone
Which lots are affected?
Lot # 10001088 exp 07/31/2024
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93265This product is part of a recall event; the main page for the event is Elcys (cysteine hydrochloride injection), USP, 500 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Elcys (cysteine hydrochloride injection), USP, 500 mg recalledElcys | Exela Pharma Sciences | Particulate Matter | Nationwide | |
| CLASS I | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Particulate Matter | Nationwide |
More recalls from Exela Pharma Sciences
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Sterility | Nationwide |
| Drug | CLASS I | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | Elcys (cysteine hydrochloride injection), USP, 500 mg recalledElcys | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | 8.4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate | Exela Pharma Sciences | Foreign Material | Nationwide |
Other Midazolam recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Midazolam HCl 100 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg/, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg /, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |