FDA Drug Recalls

5,405 recalls, newest first

Jul 14, 2017 Class II · Moderate risk

Sodium Bicarbonate 8.4% Injection Solution 50 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company D-1075-2017

Jul 14, 2017 Class II · Moderate risk

Phenylephrine HCL in 0.9% Sodium Chloride 10 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-171-12 D-1074-2017

Jul 14, 2017 Class II · Moderate risk

Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-103-13 D-1073-2017

Jul 14, 2017 Class II · Moderate risk

Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-134-18 D-1072-2017

Jul 14, 2017 Class II · Moderate risk

Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-288-18 D-1071-2017

Jul 14, 2017 Class II · Moderate risk

Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-217-18 D-1070-2017

Jul 14, 2017 Class II · Moderate risk

Succinylcholine Chloride Injection Solution 5 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-067-15 D-1069-2017

Jul 14, 2017 Class II · Moderate risk

Succinylcholine Chloride Injection Solution 10 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-067-12 D-1068-2017

Jul 14, 2017 Class II · Moderate risk

Glycopyrrolate Injection Solution

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-028-45 D-1067-2017

Jul 14, 2017 Class II · Moderate risk

Glycopyrrolate Injection Solution

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-028-16 D-1066-2017

Jul 14, 2017 Class II · Moderate risk

Glycopyrrolate Injection Solution

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-028-15 D-1065-2017

Jul 14, 2017 Class II · Moderate risk

Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-118-15 D-1064-2017

Jul 14, 2017 Class II · Moderate risk

Ephedrine Sulfate Injection Solution 1 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-258-45 D-1063-2017

Jul 14, 2017 Class II · Moderate risk

Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-019-15 D-1062-2017

Jul 14, 2017 Class II · Moderate risk

Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL

Lack of Sterility Assurance.

Terminated Sterility / contamination Cantrell Drug Company NDC 52533-019-12 D-1061-2017

Jul 14, 2017 Class II · Moderate risk

fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0260-40 D-1034-2017

Jul 14, 2017 Class II · Moderate risk

Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0833-40 D-1033-2017

Jul 14, 2017 Class II · Moderate risk

Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0832-40 D-1032-2017

Jul 14, 2017 Class II · Moderate risk

PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0820-40 D-1031-2017

Jul 14, 2017 Class II · Moderate risk

PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0816-40 D-1030-2017

Jul 14, 2017 Class II · Moderate risk

PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0815-40 D-1029-2017

Jul 14, 2017 Class II · Moderate risk

PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0813-40 D-1028-2017

Jul 14, 2017 Class II · Moderate risk

PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0812-40 D-1027-2017

Jul 14, 2017 Class II · Moderate risk

PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0811-59 D-1026-2017

Jul 14, 2017 Class II · Moderate risk

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag

Lack of Assurance of Sterility; product has the potential to leak.

Terminated Sterility / contamination SCA Pharmaceuticals NDC 70004-0811-40 D-1025-2017

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061