Class II · Moderate risk
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Is Midazolam recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Midazolam (43 total). Check the affected lots below.
Most common reason: Sterility / contamination (23 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Midazolam. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Midazolam recalls on record
none so far in 2026; 43 on record, newest first
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
Class II · Moderate risk
midazolam in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
midazolam in dextrose 5%
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Midazolam in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam 1mg/Ml in Nacl 0.9% Inj Syr C-Iv
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam 1mg/Ml in Nacl 0.9% Inj Sol Syr
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam Benzodiazepine 50 mg/50 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Midazolam 0.5mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Midazolam 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Midazolam 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Midazolam HCl Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Midazolam HCl in 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Midazolam HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class I · High risk
Midazolam Injection
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
Class II · Moderate risk
Midazolam HCL 100 mg
Lack of Assurance of Sterility.
Class II · Moderate risk
Midazolam HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Midazolam Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam HCI 1mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility
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