Independent register of U.S. FDA drug recalls · updated Oct 13, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,543 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

fentaNYL 550 mcg/55 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1274-50 D-0572-2020
Class II · Moderate risk

fentaNYL 1500 mcg/30 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1180-79 D-0570-2020
Class II · Moderate risk

fentaNYL 2500 mcg/50 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1436-76 D-0569-2020
Class II · Moderate risk

fentaNYL 800 mcg/200 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1436-76 D-0568-2020
Class II · Moderate risk

fentaNYL 1000 mcg/20 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1415-47 D-0566-2020
Class II · Moderate risk

fentaNYL 200 mcg/100 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1103-36 D-0565-2020
Class II · Moderate risk

fentaNYL 400 mcg/200 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1441-76 D-0564-2020
Class II · Moderate risk

fentaNYL 400 mcg/200 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1207-37 D-0562-2020
Class II · Moderate risk

fentaNYL 200 mcg/100 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1108-36 D-0561-2020
Class II · Moderate risk

fentaNYL 250 mcg/5 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1098-44 D-0560-2020
Class II · Moderate risk

fentaNYL 200 mcg/100 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1255-75 D-0559-2020
Class II · Moderate risk

fentaNYL 2750 mcg/55 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1100-50 D-0558-2020
Class II · Moderate risk

fentaNYL 200 mcg/100 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1202-75 D-0557-2020
Class II · Moderate risk

fentaNYL 100 mcg/2 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1097-43 D-0556-2020
Class II · Moderate risk

fentaNYL 400 mcg/200 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1440-76 D-0554-2020
Class II · Moderate risk

fentaNYL 500 mcg/250 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1225-37 D-0552-2020
Class II · Moderate risk

fentaNYL 1500 mcg/30 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1099-49 D-0551-2020
Class II · Moderate risk

fentaNYL 200 mcg/100 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1104-36 D-0550-2020
Class II · Moderate risk

fentaNYL 500 mcg/250 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1269-37 D-0549-2020
Class II · Moderate risk

fentaNYL 200 mcg/100 mL

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Terminated Particulate / foreign matter QuVa Pharma, Inc. NDC 70092-1259-75 D-0548-2020

Recalls by year