Diovan (valsartan) 160 mg, 90 tablets, Rx only,… was recalled on August 4, 2026 in cooperation with the U.S. Food and Drug Administration because failed Dissolution Specifications.
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Lot AV5913C, Expiry: 6/2027
Where it was sold: US Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Dissolution Specifications
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Novartis Pharmaceuticals Corporation
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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