FDA-Drug2026-08-19Class IIPROCESSING DEFECT

Novartis Diovan 160 mg tablets recalled for failed dissolution specifications

OTHERNationwide distributionDrugs

What this means

One lot of Novartis Diovan (valsartan) 160 mg tablets failed to meet dissolution specifications, which means the tablets may not dissolve properly in the body. This could affect how well the medication works. The affected lot (AV5913C, expiring 6/2027) was distributed nationwide.

  • Check your Diovan bottle for lot number AV5913C and expiration date of 6/2027.
  • If you have this lot, contact your pharmacy or doctor before stopping your medication.
  • Do not stop taking your blood pressure medication without medical guidance.
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The agency's original wording
Hazard

Failed Dissolution Specifications

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide
Manufactured in
1 Health Plz, East Hanover, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0746-2026

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