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Home > Recalled Products > Drugs > Elevated Impurity > Legacy Losartan Potassium USP

Recall: Legacy Losartan Potassium USP

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On 2019-04-24, the FDA announced that Legacy Pharmaceutical Packaging is conducting a recall on Losartan Potassium USP due to a possible . The recalled products were sold under the brand name(s) Legacy during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 9 drugs recalls due to potential elevated impurity, including losartan potassium tablets, usp, 25mg, 50mg, and 100mg, losartan potassium tablets, usp, 50mg and more. Additionally, there have been 19 drug and medical device recalls due to other health hazards as well as 84 food recalls.

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Losartan Potassium Tablets USP 50 mg, Label
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Legacy Pharmaceutical Packaging
Phone: 1-877-538-8443

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Detailed Recall Information



Regions Where Sold: Nationwide

Product Description: Losartan Potassium USP

Brand Name(s): Legacy

Reason for Recall: N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity

Official Recall Date: 2019-04-24


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Additional information provided by the FDA.gov:

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). 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.

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