Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 recalls, newest first.

Class II · Moderate risk

Sodium Chloride Injection

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Terminated Sterility / contamination Baxter Healthcare Corp. NDC 0338-0049-11 D-628-2013
Class II · Moderate risk

Lidocaine Hydrochloride and 5% Dextrose Injection

Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Terminated Sterility / contamination Baxter Healthcare Corp. D-627-2013
Class II · Moderate risk

Heparin Sodium and 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Terminated Sterility / contamination Baxter Healthcare Corp. NDC 0338-0433-04 D-626-2013
Class II · Moderate risk

5% Dextrose Injection

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Terminated Sterility / contamination Baxter Healthcare Corp. NDC 0338-0017-31 D-625-2013
Class II · Moderate risk

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Terminated Sterility / contamination Baxter Healthcare Corp. NDC 0338-0553-11 D-624-2013
Class II · Moderate risk

Ondansetron Injection

Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot

Terminated Particulate / foreign matter Hospira, Inc. NDC 0409-4755-03 D-851-2013
Class II · Moderate risk

Enablex (darifenacin)

Failed Impurities/Degradation Specifications: unspecified degradation product

Terminated Impurity / degradation Warner Chilcott US LLC NDC 0078-9420-07 D-822-2013
Class II · Moderate risk

Ranitidine Syrup

Failed Impurity/Degradation Specification; "Related Compound C"

Terminated Impurity / degradation Actavis South Atlantic LLC D-829-2013
Class II · Moderate risk

Proplete 45 - 51 KG

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Terminated Sterility / contamination Pentec Health D-592-2013
Class II · Moderate risk

Proplete 90+ KG

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Terminated Sterility / contamination Pentec Health D-591-2013
Class II · Moderate risk

Proplete 80+ KG

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Terminated Sterility / contamination Pentec Health D-590-2013
Class II · Moderate risk

Proplete 70+ KG

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions

Terminated Sterility / contamination Pentec Health D-589-2013
Class II · Moderate risk

Proplete 60 - 69 KG

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Terminated Sterility / contamination Pentec Health D-588-2013
Class II · Moderate risk

Proplete 52 - 59 KG

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Terminated Sterility / contamination Pentec Health D-587-2013
Class II · Moderate risk

Proplete 40 - 44 KG

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Terminated Sterility / contamination Pentec Health D-586-2013
Class II · Moderate risk

Idpn

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Terminated Sterility / contamination Pentec Health D-585-2013

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