US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

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

Medique Pain-Off

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

Medique Products D-0390-2022
Class II · Moderate risk Terminated

Physicians CARE Extra Strength PAIN RELIEVER

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

Medique Products D-0389-2022
Class II · Moderate risk Terminated

B-Complex

Reason Lack of Processing Controls

Valgene Incorporated dba Cape Drugs D-0284-2022
Class II · Moderate risk Terminated

Methylcobalamin 12mg/ml injection

Reason Lack of Processing Controls

Valgene Incorporated dba Cape Drugs D-0283-2022
Class II · Moderate risk Terminated

Carbamazepine Tablets

Reason Failed Dissolution Specifications

Torrent Pharma Inc. NDC 13668-268-01 D-0365-2022
Class II · Moderate risk Ongoing

Lidocaine Hydrochloride

Reason Superpotent Drug: Minimally superpotent

Teligent Pharma, Inc. NDC 63739-997-64 D-0296-2022
Class II · Moderate risk Terminated

5% Dextrose Injection

Reason Lack of sterility assurance: bag has the potential to leak.

Pfizer Inc. NDC 0409-7100-68 D-0265-2022