FDA Drug Recalls

295 recalls · Class II, newest first

Dec 31, 2021 Class II · Moderate risk

Norepinephrine Bitartrate Injection USP 4 mg/4 mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Teva Pharmaceuticals USA NDC 0703-1153-03 D-0371-2022

Dec 31, 2021 Class II · Moderate risk

MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Teva Pharmaceuticals USA NDC 16714-090-01 D-0370-2022

Dec 21, 2021 Class II · Moderate risk

Medroxyprogesterone Acetate Injection

Lack of Assurance of Sterility

Ongoing Sterility / contamination Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy D-0463-2022

Dec 6, 2021 Class II · Moderate risk

Vancomycin HCl in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1459-01 D-0427-2022

Dec 6, 2021 Class II · Moderate risk

Vancomycin HCl in 0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1458-01 D-0426-2022

Dec 6, 2021 Class II · Moderate risk

Vancomycin HCl in 0.9 % Sodium Chloride Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1456-01 D-0425-2022

Dec 6, 2021 Class II · Moderate risk

Vancomycin HCl

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-0736-01 D-0424-2022

Dec 6, 2021 Class II · Moderate risk

Betadine (povidone-iodine)

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1680-01 D-0423-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-0859-03 D-0422-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-0993-01 D-0421-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl/Tropicamide

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-0815-01 D-0420-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl/Lidocaine

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1118-01 D-0419-2022

Dec 6, 2021 Class II · Moderate risk

PHENYLephrine

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1667-01 D-0418-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1652-01 D-0417-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1544-10 D-0416-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl 0.5 mg/5mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1545-05 D-0415-2022

Dec 6, 2021 Class II · Moderate risk

Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1270-01 D-0414-2022

Dec 6, 2021 Class II · Moderate risk

Phenol

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1476-05 D-0413-2022

Dec 6, 2021 Class II · Moderate risk

Mvasi

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1661-13 D-0412-2022

Dec 6, 2021 Class II · Moderate risk

Neostigmine methylsulfate

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1549-05 D-0411-2022

Dec 6, 2021 Class II · Moderate risk

Moxifloxacin

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1050-01 D-0410-2022

Dec 6, 2021 Class II · Moderate risk

Mitomycin-C

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1011-01 D-0409-2022

Dec 6, 2021 Class II · Moderate risk

Mitomycin-C Sterile Ophthalmic Solution

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1009-01 D-0408-2022

Dec 6, 2021 Class II · Moderate risk

Mitomycin-C

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1416-01 D-0407-2022

Dec 6, 2021 Class II · Moderate risk

Methotrexate

Lack of Assurance of Sterility

Terminated Sterility / contamination Edge Pharma, LLC NDC 05446-1505-05 D-0406-2022

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