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

6 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

DULoxetine DR USP

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-0163-2025
Class II · Moderate risk

Cinacalcet Tablets

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Terminated Nitrosamine impurity Accord Healthcare, INC. D-0032-2025
Class II · Moderate risk

Cinacalcet Tablets

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Terminated Nitrosamine impurity Accord Healthcare, INC. D-0031-2025
Class II · Moderate risk

Cinacalcet Tablets 30 mg

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Terminated Nitrosamine impurity Accord Healthcare, INC. D-0030-2025
Class II · Moderate risk

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

Terminated Nitrosamine impurity Golden State Medical Supply Inc. NDC 60429-165-30 D-0568-2024

Recalls by year