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

Profound-PE Dental Gel

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0408-10 D-0442-2022
Class II · Moderate risk Terminated

Profound-PE Dental Gel

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1018-10 D-0441-2022
Class II · Moderate risk Terminated

Profound Dental Gel

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0407-10 D-0440-2022
Class II · Moderate risk Terminated

Profound Dental Gel

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0790-10 D-0439-2022
Class II · Moderate risk Terminated

LET Topical Gel

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0607-01 D-0437-2022
Class II · Moderate risk Terminated

LT Topical Cream

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1647-01 D-0436-2022
Class II · Moderate risk Terminated

Dibutyl Squaric Acid

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1156-03 D-0435-2022
Class II · Moderate risk Terminated

Dibutyl Squaric Acid

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1047-03 D-0434-2022
Class II · Moderate risk Terminated

CSF Otic Insufflation Capsule

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1633-05 D-0431-2022
Class II · Moderate risk Terminated

Cantharidin PLUS

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-0970-03 D-0430-2022
Class II · Moderate risk Terminated

BLT Topical Cream

Reason CGMP Deviations

Edge Pharma, LLC NDC 05446-1235-01 D-0428-2022
Class II · Moderate risk Terminated

Vancomycin HCl

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-0736-01 D-0424-2022
Class II · Moderate risk Terminated

Betadine

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1680-01 D-0423-2022
Class II · Moderate risk Terminated

Phenylephrine HCl/Tropicamide

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-0815-01 D-0420-2022
Class II · Moderate risk Terminated

Phenylephrine HCl/Lidocaine

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1118-01 D-0419-2022
Class II · Moderate risk Terminated

PHENYLephrine

Reason Lack of Assurance of Sterility

Edge Pharma, LLC NDC 05446-1667-01 D-0418-2022