Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

948 recalls · Class II, 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

Glimepiride Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Amerisource Health Services LLC NDC 68001-179-00 D-0759-2023
Class II · Moderate risk

Glimepiride Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Amerisource Health Services LLC NDC 68001-178-00 D-0758-2023
Class II · Moderate risk

Glimepiride Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Amerisource Health Services LLC NDC 68001-177-00 D-0757-2023
Class II · Moderate risk

Tadalafil Tablets

CGMP Deviations

Ongoing cGMP deviation Northwind Pharmaceuticals LLC NDC 51655-487-52 D-0554-2023
Class II · Moderate risk

Tadalafil Tablets

CGMP Deviations

Ongoing cGMP deviation Northwind Pharmaceuticals LLC NDC 51655-473-87 D-0553-2023
Class II · Moderate risk

Doxazosin Tablets

CGMP Deviations

Ongoing cGMP deviation Northwind Pharmaceuticals LLC NDC 51655-109-52 D-0550-2023
Class II · Moderate risk

Dianeal Low Calcium

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Completed Sterility / contamination Baxter Healthcare Corporation NDC 0941-0409-07 D-0542-2023
Class II · Moderate risk

Dabigatran Etexilate Capsules

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ongoing Nitrosamine impurity Ascend Laboratories, LLC NDC 67877-474-60 D-0533-2023
Class II · Moderate risk

Simvastatin

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0431-90 D-0486-2023
Class II · Moderate risk

Simvastatin

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0446-30 D-0485-2023
Class II · Moderate risk

Simvastatin

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0688-30 D-0484-2023
Class II · Moderate risk

Simvastatin

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0710-90 D-0483-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0250-30 D-0482-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0488-30 D-0481-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0723-30 D-0480-2023
Class II · Moderate risk

Ropinirole

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 72189-0364-30 D-0479-2023

Recalls by year