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

Fentanyl Citrate 50 mcg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0964-70 D-1337-2016
Class II · Moderate risk Terminated

Cefazolin 1GM in Sterile Water

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0960-72 D-1335-2016
Class II · Moderate risk Terminated

Ondansetron 2mg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0957-69 D-1334-2016
Class II · Moderate risk Terminated

Rocuronium 10 mg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0955-70 D-1333-2016
Class II · Moderate risk Terminated

Lidocaine 2%

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0946-70 D-1332-2016
Class II · Moderate risk Terminated

Phenylephrine HCI

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0934-70 D-1327-2016
Class II · Moderate risk Terminated

Succinylcholine Chloride 20 mg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0920-72 D-1322-2016
Class II · Moderate risk Terminated

Morphine Sulfate

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0877-41 D-1317-2016
Class II · Moderate risk Terminated

Morphine Sulfate 1mg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0876-41 D-1316-2016
Class II · Moderate risk Terminated

Fentanyl Citrate 10 mcg/mL

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0869-48 D-1314-2016