Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg Recalled by Aurobindo Pharma USA 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 Aurobindo Pharma USA Inc. directly.
Affected Products
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
Quantity: 92,616 bottles
Why Was This Recalled?
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (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?
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
About Aurobindo Pharma USA Inc.
Aurobindo Pharma USA Inc. has 47 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report