Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Recalled by Sandoz, Inc Due to CGMP Deviations: FDA lab confirmed presence an impurity,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz, Inc directly.
Affected Products
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
Quantity: 170 HDPE bottles
Why Was This Recalled?
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Where Was This Sold?
This product was distributed to 1 state: OH
About Sandoz, Inc
Sandoz, Inc has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report