Is Losartan recalled?

117 FDA recalls mention Losartan. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Losartan.

Class II · Moderate risk Terminated Apr 6, 2022

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx…

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

RemedyRepack Inc. NDC 70518-3282-1 D-0788-2022

Class II · Moderate risk Terminated Mar 31, 2022

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count…

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-216-06 D-0843-2022

Class II · Moderate risk Terminated Mar 31, 2022

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count…

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-217-06 D-0842-2022

Class II · Moderate risk Terminated Mar 31, 2022

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count…

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-215-06 D-0841-2022

Class II · Moderate risk Terminated Mar 31, 2022

Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx…

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-378-03 D-0840-2022

Class II · Moderate risk Terminated Mar 31, 2022

Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx…

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-377-03 D-0839-2022

Class II · Moderate risk Terminated Mar 31, 2022

Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx…

Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Lupin Pharmaceuticals Inc. NDC 68180-376-03 D-0838-2022

Class II · Moderate risk Terminated Aug 6, 2020

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ…

Reason Failed Tablet/Capsule Specification; complaint of bulging tablet

Hetero Labs Limited (Unit V) D-1545-2020

Class II · Moderate risk Terminated Apr 3, 2020

Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct…

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

Golden State Medical Supply Inc. NDC 60429-316-30 D-1238-2020

Class II · Moderate risk Terminated Mar 26, 2020

Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count…

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

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

Class II · Moderate risk Terminated Mar 26, 2020

Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC…

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

Avet Pharmaceuticals, Inc. NDC 23155-645-03 D-1103-2020

Class II · Moderate risk Ongoing Mar 25, 2020

LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by…

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

Teva Pharmaceuticals USA NDC 0591-3747-00 D-1102-2020

Class II · Moderate risk Ongoing Mar 25, 2020

LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by…

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

Teva Pharmaceuticals USA NDC 0591-3746-00 D-1101-2020

Class II · Moderate risk Ongoing Mar 25, 2020

LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by…

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

Teva Pharmaceuticals USA NDC 0591-3745-00 D-1100-2020

Class II · Moderate risk Ongoing Sep 19, 2019

Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma…

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

Torrent Pharma Inc. D-0124-2020

Class II · Moderate risk Ongoing Sep 19, 2019

Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent…

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

Torrent Pharma Inc. D-0123-2020

Class II · Moderate risk Ongoing Sep 19, 2019

Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking…

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

Torrent Pharma Inc. D-0122-2020

Class II · Moderate risk Ongoing Sep 19, 2019

Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ…

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

Torrent Pharma Inc. D-0121-2020

Class II · Moderate risk Terminated Jun 20, 2019

Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA…

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

Macleods Pharma Usa Inc NDC 33342-052-10 D-1461-2019

Class II · Moderate risk Terminated Jun 20, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA…

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

Macleods Pharma Usa Inc NDC 33342-051-10 D-1460-2019

Class II · Moderate risk Terminated Jun 20, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc…

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

Macleods Pharma Usa Inc NDC 33342-050-10 D-1459-2019

Class II · Moderate risk Terminated Jun 20, 2019

Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536…

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

Macleods Pharma Usa Inc NDC 33342-045-44 D-1458-2019

Class II · Moderate risk Terminated Jun 20, 2019

Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536…

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

Macleods Pharma Usa Inc NDC 33342-045-10 D-1457-2019

Class II · Moderate risk Terminated Jun 14, 2019

Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90

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

Golden State Medical Supply Inc. NDC 60429-318-90 D-1465-2019

Class II · Moderate risk Terminated Jun 14, 2019

Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10

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

Golden State Medical Supply Inc. NDC 60429-317-10 D-1464-2019

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