US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Phenylephrine HCl

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1652-01 D-0417-2022
Class II · Moderate risk Terminated

Phenylephrine HCl

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1544-10 D-0416-2022
Class II · Moderate risk Terminated

Phenylephrine HCl 0.5 mg/5mL

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1545-05 D-0415-2022
Class II · Moderate risk Terminated

Phenol

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1476-05 D-0413-2022
Class II · Moderate risk Terminated

Mvasi

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1661-13 D-0412-2022
Class II · Moderate risk Terminated

Neostigmine methylsulfate

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1549-05 D-0411-2022
Class II · Moderate risk Terminated

Moxifloxacin

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1050-01 D-0410-2022
Class II · Moderate risk Terminated

Mitomycin-C

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1011-01 D-0409-2022
Class II · Moderate risk Terminated

Mitomycin-C

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1416-01 D-0407-2022
Class II · Moderate risk Terminated

Methotrexate

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1505-05 D-0406-2022
Class II · Moderate risk Terminated

Lidocaine HCL / Bupivacaine HCL

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1548-18 D-0404-2022
Class II · Moderate risk Terminated

Gemcitabine

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1566-50 D-0403-2022
Class II · Moderate risk Terminated

Edetate Disodium

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1428-10 D-0401-2022
Class II · Moderate risk Terminated

Edetate Disodium

Reason Lack of Assurance of Sterility.

Edge Pharma, LLC NDC 05446-1427-10 D-0400-2022
Class II · Moderate risk Terminated

Dexamethasone sodium phosphate

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-0848-01 D-0399-2022
Class II · Moderate risk Terminated

Cefuroxime

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1003-01 D-0398-2022
Class II · Moderate risk Terminated

Ceftazidime

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-0733-01 D-0397-2022
Class II · Moderate risk Terminated

Lidocaine HCl/Epinephrine

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1268-01 D-0396-2022
Class II · Moderate risk Terminated

ALUM Concentrate

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-0637-03 D-0394-2022
Class II · Moderate risk Terminated

Extra Strength Headache

Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Medique Products D-0391-2022