Macleods Pharma USA Inc. is recalling approximately 368,691 bottles of Losartan Potassium and Losartan Potassium/Hydrochlorothiazide tablets because an impurity called N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active ingredient. This recall affects several strengths and bottle sizes, including 50 mg, 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg. Consumers should not stop taking their blood pressure medication without consulting a doctor first, as the risk of stopping the medication suddenly may be greater than the risk of the impurity.
The impurity NMBA is a known environmental contaminant and potential human carcinogen, meaning long-term exposure could increase the risk of cancer. While no adverse events have been reported for this specific recall, the chemical was found at levels exceeding the FDA's acceptable daily intake limits.
Refund for unused medication.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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