Recall: Losartan Potassium Hydrochlorothiazide Tablets
On 2018-11-08, the FDA announced that Sandoz is conducting a recall on Potassium Hydrochlorothiazide Tablets due to a possible ndea (n-nitrosodiethylamine). The recalled products were sold under the brand name(s) Losartan during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 5 drugs recalls due to potential elevated impurity, including irbesartan tablets, irbesartan tablets, usp 75 mg, 150 mg, and 300 mg dosage forms and more. Additionally, there have been 21 drug and medical device recalls due to other health hazards as well as 80 food recalls.
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Potassium Hydrochlorothiazide Tablets
Brand Name(s): Losartan
Reason for Recall: NDEA (N-Nitrosodiethylamine) Impurity
Official Recall Date: 2018-11-08
Additional information provided by the FDA.gov:
Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC). Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.