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

58 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

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
Class II · Moderate risk

Losartan Potassium Tablets USP 50 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 23155-645-03 D-1103-2020
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-3747-00 D-1102-2020
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-3746-00 D-1101-2020
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-3745-00 D-1100-2020
Class II · Moderate risk

Ranitidine 300 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Direct Rx NDC 61919-455-30 D-0017-2021
Class II · Moderate risk

Ranitidine 150 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Direct Rx NDC 61919-339-60 D-0016-2021

Recalls by year