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Valsartan

FDA recalls

9 rows

Date	Company and reason	Class
Aug 3, 2026	Novartis Pharmaceuticals Corporation Failed Dissolution Specifications	Class II · Ongoing
Mar 14, 2021	Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Class II · Terminated
Dec 30, 2018	Aurobindo Pharma USA Inc. GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.	Class II · Ongoing
Dec 30, 2018	Aurobindo Pharma USA Inc. 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.	Class II · Ongoing
Aug 13, 2018	Jubilant Cadista Pharmaceuticals, Inc. Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.	Class III · Terminated
Aug 7, 2018	Hetero Labs Limited Unit V CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II · Completed
Jul 26, 2018	Bryant Ranch Prepack Inc. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II · Terminated
Jul 12, 2018	Prinston Pharmaceutical Inc CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II · Ongoing
Nov 28, 2017	Prinston Pharmaceutical Inc Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.	Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).