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Independent register of U.S. FDA drug recalls · updated Oct 13, 2026

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.

Dec 20, 2019 Class II · Moderate risk

FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0730-2020

Dec 20, 2019 Class II · Moderate risk

FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0729-2020

Dec 20, 2019 Class II · Moderate risk

FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0728-2020

Dec 20, 2019 Class II · Moderate risk

FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0727-2020

Dec 20, 2019 Class II · Moderate risk

FENT 600MCG/ SUF 800MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0726-2020

Dec 20, 2019 Class II · Moderate risk

CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0725-2020

Dec 20, 2019 Class II · Moderate risk

CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0724-2020

Dec 20, 2019 Class II · Moderate risk

CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0723-2020

Dec 20, 2019 Class II · Moderate risk

CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0722-2020

Dec 20, 2019 Class II · Moderate risk

CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0721-2020

Dec 20, 2019 Class II · Moderate risk

CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0720-2020

Dec 20, 2019 Class II · Moderate risk

BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0719-2020

Dec 20, 2019 Class II · Moderate risk

BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0718-2020

Dec 20, 2019 Class II · Moderate risk

BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0717-2020

Dec 20, 2019 Class II · Moderate risk

BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0716-2020

Dec 20, 2019 Class II · Moderate risk

BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0715-2020

Dec 20, 2019 Class II · Moderate risk

BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0714-2020

Dec 20, 2019 Class II · Moderate risk

BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0713-2020

Dec 20, 2019 Class II · Moderate risk

Bup 5mg/ Hydrom 15mg/ Suf 600mcg/Ml

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0712-2020

Dec 20, 2019 Class II · Moderate risk

BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0711-2020

Dec 20, 2019 Class II · Moderate risk

BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0710-2020

Dec 20, 2019 Class II · Moderate risk

BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0709-2020

Dec 20, 2019 Class II · Moderate risk

BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0708-2020

Dec 20, 2019 Class II · Moderate risk

BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0707-2020

Dec 20, 2019 Class II · Moderate risk

BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0706-2020

Recalls by year

2026572
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061