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

37 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2020 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Metformin HCL E/R 500 mg

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Terminated Nitrosamine impurity Direct Rx NDC 72189-064-90 D-0058-2021
Class II · Moderate risk

metformin HCL ER 500 mg

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-0059-2021
Class II · Moderate risk

Time-Cap Labs

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Terminated Nitrosamine impurity Marksans Pharma Limited NDC 49483-624-01 D-0062-2021
Class II · Moderate risk

Time-Cap Labs

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Terminated Nitrosamine impurity Marksans Pharma Limited NDC 49483-623-09 D-0061-2021
Class II · Moderate risk

Time-Cap Labs

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Terminated Nitrosamine impurity Marksans Pharma Limited NDC 49483-623-01 D-1356-2020
Class II · Moderate risk

metFORMIN HCL ER 500 mg

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. NDC 72789-009-30 D-1333-2020
Class II · Moderate risk

metFORMIN HCL ER USP 500 mg

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-1307-2020
Class II · Moderate risk

Nizatidine Oral Solution

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Terminated Nitrosamine impurity Amneal Pharmaceuticals of New York, LLC NDC 60846-301-15 D-1253-2020
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.

Terminated Nitrosamine impurity Golden State Medical Supply Inc. NDC 60429-316-30 D-1238-2020
Class II · Moderate risk

Losartan Potassium Tablets USP 100 mg

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level

Terminated Nitrosamine impurity Avet Pharmaceuticals, Inc. NDC 23155-646-03 D-1104-2020

Recalls by year