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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

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Denton Pharma, Inc. NDC 70934-017-04 D-0794-2020

Dec 20, 2019 Class II · Moderate risk

Trimix Super

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0779-2020

Dec 20, 2019 Class II · Moderate risk

TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0778-2020

Dec 20, 2019 Class II · Moderate risk

Trimix Forte 4

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0777-2020

Dec 20, 2019 Class II · Moderate risk

TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0776-2020

Dec 20, 2019 Class II · Moderate risk

Trimix -A (713)

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0775-2020

Dec 20, 2019 Class II · Moderate risk

Trimix (713)

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0774-2020

Dec 20, 2019 Class II · Moderate risk

TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0773-2020

Dec 20, 2019 Class II · Moderate risk

TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0772-2020

Dec 20, 2019 Class II · Moderate risk

Testosterone Cyp 200mg/Ml Oil

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0771-2020

Dec 20, 2019 Class II · Moderate risk

TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0770-2020

Dec 20, 2019 Class II · Moderate risk

SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0769-2020

Dec 20, 2019 Class II · Moderate risk

SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0768-2020

Dec 20, 2019 Class II · Moderate risk

SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0767-2020

Dec 20, 2019 Class II · Moderate risk

QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0766-2020

Dec 20, 2019 Class II · Moderate risk

QUADMIX FORTE in 1 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0765-2020

Dec 20, 2019 Class II · Moderate risk

QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0764-2020

Dec 20, 2019 Class II · Moderate risk

QUADMIX in 1 mL vial Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0763-2020

Dec 20, 2019 Class II · Moderate risk

PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0762-2020

Dec 20, 2019 Class II · Moderate risk

MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0761-2020

Dec 20, 2019 Class II · Moderate risk

MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0760-2020

Dec 20, 2019 Class II · Moderate risk

MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0759-2020

Dec 20, 2019 Class II · Moderate risk

MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0758-2020

Dec 20, 2019 Class II · Moderate risk

MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0757-2020

Dec 20, 2019 Class II · Moderate risk

MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion

Lack of sterility assurance.

Terminated Sterility / contamination Assurance Infusion D-0756-2020

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