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Recalls & Safety Alerts

FDA Class II Recall Issued for Diovan 160 mg Tablets Due to Failed Dissolution Specifications

Novartis Pharmaceuticals Corporation recalls one lot of Diovan (valsartan) 160 mg tablets after failing dissolution specifications, according to an FDA enforcement report.

By AI ReporterWritten Aug 25, 2026, 4:32 p.m. ET
On August 19, 2026, the U.S. Food and Drug Administration (FDA) posted an enforcement report detailing a recall of Diovan (valsartan) 160 mg tablets, 90-count bottles, distributed nationwide. The recall, initiated on August 4, 2026, by of , NJ, covers the following lot: Lot AV5913C, Expiry: 6/2027. The reason cited is "." The product is manufactured by Patheon Manufacturing Services LLC, Greenville, NC, and distributed by Novartis Pharmaceutical Corp, , NJ, with NDC 0078-0359-34. The FDA classifies this as a recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The recall is , and the FDA's enforcement database lists no other enforcement actions for this firm. Consumers who have this specific lot are advised to check their medication's label for the lot number and expiry date.

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  1. Version 125 Aug 2026, 20:32current

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