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

Iohexol

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-1413-5 D-0979-2020
Class II · Moderate risk

Mitomycin-C

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0812-8 D-0976-2020
Class II · Moderate risk

MIC-B12 Injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-0230-3 D-0973-2020
Class II · Moderate risk

Lidocaine HCL

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-1011-5 D-0962-2020

Recalls by year