Independent register of U.S. FDA drug recalls · updated Oct 10, 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.

14,535 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

Methylcobalamin

Lack of Assurance of Sterility; reports of adverse events after injection

Terminated Sterility / contamination NuVision Pharmacy, Inc. D-417-2013
Class II · Moderate risk

Verapamil Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-881-2013
Class II · Moderate risk

Vancomycin Ophthalmic PF

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-880-2013
Class II · Moderate risk

Trimix Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-879-2013
Class II · Moderate risk

Testosterone Cypionate Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-878-2013
Class II · Moderate risk

Tacrolimus Ophthalmic

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-875-2013
Class II · Moderate risk

Quadmix Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-874-2013
Class II · Moderate risk

Nandrolone Decanoate Injectable

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-873-2013
Class II · Moderate risk

MIC with B6 and B12

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-872-2013
Class II · Moderate risk

Methylcobalamin PF

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-871-2013
Class II · Moderate risk

Hydroxyprogesterone CAPR.

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-870-2013
Class II · Moderate risk

HCG Chorionic Gonadotropin

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-869-2013

Recalls by year