US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

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

Losartan Potassium Tablets

Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Torrent Pharma Inc. D-1264-2019
Class II · Moderate risk Terminated

Volumex

Reason Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Iso-Tex Diagnostics, Inc NDC 50914-7720-8 D-1136-2019
Class II · Moderate risk Terminated

DelNido Cardioplegia

Reason Lack of sterility assurance.

CMC Enterprise Pharmacy D-1240-2019
Class II · Moderate risk Terminated

Sodium Citrate 4%

Reason Lack of sterility assurance.

CMC Enterprise Pharmacy D-1234-2019
Class II · Moderate risk Terminated

Phenylephrine 0.8 mg/10 mL NS

Reason Lack of sterility assurance.

CMC Enterprise Pharmacy D-1230-2019
Class II · Moderate risk Terminated

Heparin Pork 30

Reason Lack of sterility assurance.

CMC Enterprise Pharmacy D-1229-2019
Class II · Moderate risk Terminated

Chlorothiazide 100 mg

Reason Lack of sterility assurance.

CMC Enterprise Pharmacy D-1228-2019
Class II · Moderate risk Terminated

CefTRIAXone 1 GM

Reason Lack of sterility assurance.

CMC Enterprise Pharmacy D-1227-2019
Class II · Moderate risk Terminated

CeFAZolin 3 gm 100 mg/mL

Reason Lack of sterility assurance.

CMC Enterprise Pharmacy D-1226-2019