heparin 4000 units/1000mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Yes — there is an active recall. 1 ongoing FDA recall mention Heparin (118 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Heparin. “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.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Subpotent: Low anti-factor IIa Potency.
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 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.
Subpotent Drug: low Anti-Factor IIa potency.
Labeling: Not elsewhere classified
Lack of assurance of sterility: Bags have the potential to leak.
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