Diovan Tablet
FDA Recall NDC 0078-1245
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Diovan (NDC 0078-1245). A significant event, classified as Class II, was initiated on Aug 04, 2026 by Novartis Pharmaceuticals Corporation. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Aug 04, 2026
Aug 19, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99552
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Novartis Pharmaceuticals Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lot AV5913C, Expiry: 6/2027
Affected Packages Involved in this Recall
0078-0423-15Product
0078-0358-34Product
0078-1245-34Product
0078-0359-34Product
0078-1252-34Product
0078-0360-34Product
0078-1259-34Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
