Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Valsartan Tablets USP 80 mg 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
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
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.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report