vancomycin 1 g/250 mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Yes — there is an active recall. 24 ongoing FDA recalls mention Vancomycin (149 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Vancomycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of sterility assurance
Lack of sterility assurance
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
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