Class II · Moderate risk
Diazepam Oral Solution
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Is Diazepam recalled?
Not under an active recall.
Diazepam was recalled 13 times in the past — all now closed. Most recent: Feb 9, 2022.
Most common reason: Sterility / contamination (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diazepam. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Diazepam recalls on record
none so far in 2026; 13 on record, newest first
Class II · Moderate risk
diazePAM 5 MG/ML INJECTION SOLUTION
Lack of Assurance of Sterility
Class III · Low risk
Diazepam Rectal Gel
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class II · Moderate risk
Diazepam Injection USP 10mg/2mL
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Class II · Moderate risk
Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Diazepam Injection
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Diazepam Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Diazepam 5 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Diazepam Injection
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Class II · Moderate risk
DIAZEPAM (Im/Iv)
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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