Midazolam recalls

The FDA has published 36 recalls involving Midazolam since 2012. The latest was reported on 3 Apr 2024. Most were for sterility. Pharmedium Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls36since 2012

Last 12 months0reported

Class I514% of total

Ongoing3latest 3 Apr 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 5 14%Class II 31 86%Class III 0 0%

Why midazolam is recalled

Companies

By year

202413%
2023514%
202226%
201926%
2018822%
201726%
20161028%
2014411%
201226%

Ongoing midazolam recalls

3 active

Reported	Class	Recall	Company	Reason	Where
29 Nov 2023Drug	CLASS I	Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled	Exela Pharma Sciences	Particulate Matter	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP 2mg recalled by Akorn	Akorn	Potency & Assay	Nationwide

All midazolam recalls, newest first

36 total

Reported	Class	Recall	Company	Reason	Where
3 Apr 2024Drug	CLASS II	Midazolam HCl 100 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled	Exela Pharma Sciences	Particulate Matter	Nationwide
11 Oct 2023Drug	CLASS II	midazolam in dextrose 5%, 50 mg/, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	midazolam in dextrose 5%, 50 mg /, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP 2mg recalled by Akorn	Akorn	Potency & Assay	Nationwide
5 Jan 2022Drug	CLASS II	Midazolam in 0.9% Sodium Chloride Injection, 100 mg recalled by SterRx	SterRx	Sterility	Nationwide
5 Jan 2022Drug	CLASS II	Midazolam in 0.9% Sodium Chloride Injection, 50 mg per (1 mg per mL) recalled	SterRx	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Midazolam 1MG/ML IN Nacl 0.9% Inj Sol Syr recalled by RXQ Compounding	RXQ Compounding	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Midazolam 1MG/ML IN Nacl 0.9% Inj Syr C-iv per syringe recalled	RXQ Compounding	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	Midazolam 1 mg/mL (Midazolam HCL USP 30 mg recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Midazolam HCl Injection in all strengths, all doses recalled	Pharmedium Services	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Midazolam HCl in 0.9% Sodium Chloride in all strengths recalled	Pharmedium Services	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Midazolam HCl in 5% Dextrose in all strengths, all doses recalled	Pharmedium Services	Sterility	Nationwide
10 Jan 2018Drug	CLASS I	Midazolam Injection, USP, Preservative Free, 2 mg recalledMidazolam	Fresenius Kabi USA	Packaging Defects	Nationwide
1 Nov 2017Drug	CLASS II	Midazolam HCL 100 mg (1mg/mL) Cassette in 0.9% Sodium Chloride recalled	Banner Pharmacy Services	Sterility	Nationwide
8 Feb 2017Drug	CLASS II	Midazolam Injection, USP, *25 mg/, (5 mg/ mL) vials, 10 Vials recalledMidazolam	Fresenius Kabi USA	Potency & Assay	Nationwide
21 Dec 2016Drug	CLASS II	Midazolam HCl 50 mg/ in 0.9% Sodium Chloride (1 mg/mL) recalled	Cantrell Drug	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	midazolam HCl, 1 mg per mL (3 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016Drug	CLASS II	midazolam HCl, 1 mg per mL (2 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016Drug	CLASS II	midazolam HCl, 1 mg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
20 Jul 2016Drug	CLASS II	Midazolam HCl 1mg/mL in 0.9% Sodium Chloride Intravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
13 Jul 2016Drug	CLASS II	MIDAZolam HCl 0.1 mg/mL in 5% Dextrose syringe recalled by Cantrell Drug	Cantrell Drug	Potency & Assay	Nationwide
13 Jul 2016Drug	CLASS II	Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL recalled	Cantrell Drug	Potency & Assay	Nationwide
13 Jul 2016Drug	CLASS II	Midazolam HCl in 0.9% Sodium Chloride Injection, 2 mg recalled	Cantrell Drug	Potency & Assay	Nationwide
17 Feb 2016Drug	CLASS II	Midazolam HCl Syrup, 10 mg/ unit dose cups recalled by Safecor Health	Safecor Health	Packaging Defects	NY
3 Feb 2016Drug	CLASS II	Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable recalled	Pharmakon Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Midazolam?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.