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

61 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2019 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Ongoing Nitrosamine impurity Legacy Pharmaceutical Packaging LLC NDC 68645-578-54 D-1049-2019
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Ongoing Nitrosamine impurity Legacy Pharmaceutical Packaging LLC NDC 68645-577-54 D-1048-2019
Class II · Moderate risk

Losartan Potassium Tablets

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

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1116-2019
Class II · Moderate risk

Losartan Potassium Tablets

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

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1115-2019
Class II · Moderate risk

Losartan Potassium Tablets

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

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1114-2019
Class II · Moderate risk

Losartan Potassium Tablets USP

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Ongoing Nitrosamine impurity Camber Pharmaceuticals Inc NDC 31722-702-30 D-1043-2019
Class II · Moderate risk

Losartan Potassium Tablets USP

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Ongoing Nitrosamine impurity Camber Pharmaceuticals Inc NDC 31722-701-30 D-1042-2019
Class II · Moderate risk

Losartan Potassium Tablets USP

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Ongoing Nitrosamine impurity Camber Pharmaceuticals Inc NDC 31722-700-90 D-1041-2019

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