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

Metronidazole Tablets

Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.

Terminated Failed specification Physicians Total Care, Inc. NDC 54868-0158-3 D-547-2013
Class II · Moderate risk

Xactdose Phenytoin Oral Suspension

Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume

Terminated Wrong potency / content VistaPharm, Inc. NDC 66689-035-50 D-1658-2012
Class II · Moderate risk

Methylprednisolone Tablets

Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life

Terminated Impurity / degradation Physicians Total Care, Inc. NDC 54868-2913-03 D-1391-2012
Class II · Moderate risk

Eye Drops advanced relief

Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.

Terminated Labeling / mix-up K C Pharmaceuticals Inc D-192-2013
Class II · Moderate risk

Leflunomide tablets

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Terminated Wrong potency / content Apotex Corp. NDC 60505-2503-3 D-1662-2012
Class II · Moderate risk

Leflunomide tablets

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Terminated Wrong potency / content Apotex Corp. NDC 60505-2502-1 D-1661-2012

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