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

559 recalls · Class II, newest first

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 at the manufacturer

Terminated Nitrosamine impurity Heritage Pharmaceuticals, Inc. NDC 23155-645-10 D-1287-2019
Class II · Moderate risk

Losartan Potassium Tab. USP 50mg

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

Terminated Nitrosamine impurity Preferred Pharmaceuticals, Inc NDC 68788-0048-03 D-1281-2019
Class II · Moderate risk

Losartan Potassium 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 per manufacturer

Terminated Nitrosamine impurity Direct Rx NDC 61919-952-30 D-0018-2021
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Ongoing Nitrosamine impurity Legacy Pharmaceutical Packaging LLC NDC 68645-494-54 D-1263-2019
Class II · Moderate risk

Losartan Potassium Tablets USP 25 mg 50 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 of 0.96 parts per million.

Ongoing Nitrosamine impurity AVKARE Inc. NDC 50268-516-15 D-1250-2019
Class II · Moderate risk

Losartan Potassium Tablets USP 50 mg 50 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 of 0.96 parts per million.

Ongoing Nitrosamine impurity AVKARE Inc. NDC 50268-517-15 D-1249-2019
Class II · Moderate risk

Losartan Potassium/HCTZ

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Terminated Nitrosamine impurity RemedyRepack Inc. NDC 70518-1560-00 D-1270-2019
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-1266-2019
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-1265-2019
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-1264-2019
Class II · Moderate risk

Losartan 50mg Tablet

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Terminated Nitrosamine impurity RemedyRepack Inc. D-1081-2019
Class II · Moderate risk

Valsartan Tablets 320 mg USP

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Ongoing Nitrosamine impurity Rising Pharmaceuticals, Inc. NDC 52343-125-90 D-1055-2019
Class II · Moderate risk

Valsartan Tablets 160 mg USP

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Ongoing Nitrosamine impurity Rising Pharmaceuticals, Inc. NDC 52343-124-90 D-1054-2019

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