Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amlodipine and Valsartan Tablets USP 10mg/160mg Recalled by Aurobindo Pharma USA Inc. Due to GCMP Deviations: FDA analysis confirmed presence of trace...
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
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
Quantity: N/A
Why Was This Recalled?
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Where Was This Sold?
Product was distributed to major distribution chains 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