Class II · Moderate risk
Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag
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.
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 II · Moderate risk
Midazolam
Lack of Assurance of Sterility
Class II · Moderate risk
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe
Subpotent Drug
Class II · Moderate risk
Midazolam HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
Midazolam 1 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Midazolam
Stability data does not support expiry.
Class II · Moderate risk
Midazolam
Subpotent drug.
Class II · Moderate risk
Midazolam HCl Syrup
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Class II · Moderate risk
midazolam HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
midazolam HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
midazolam HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class I · High risk
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes
Superpotent Drug: Product contains twice the stated amount of midazolam.
Class II · Moderate risk
Midazolam Hydrochloride Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Midazolam 1mg/Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Midazolam HCl Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
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