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

Glycine Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0344-3 D-0955-2020
Class II · Moderate risk

Glycerin

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0464-1 D-0954-2020
Class II · Moderate risk

Dexamethasone

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0630-1 D-0951-2020
Class II · Moderate risk

Alprostadil

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0543-2 D-0936-2020
Class II · Moderate risk

Alprostadil

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0538-2 D-0935-2020

Recalls by year