Novartis Recalls a Lot of Diovan Blood Pressure Tablets Over a Dissolution Defect
The FDA classified the recall Class II, meaning the affected tablets might not dissolve properly and could reduce how well the drug is absorbed.
Meridians Life Desk
Published 13 August 2026 · Updated 13 August 2026 · 3 min read
HealthThe short answer
- Novartis is recalling one nationwide lot of Diovan (valsartan) 160 mg tablets, lot AV5913C, because it failed dissolution testing.
- The FDA classified the recall Class II, indicating a low-to-moderate risk of temporary or reversible health effects.
- The affected 90-tablet bottles expire in June 2027 and were manufactured by Patheon Manufacturing Services in North Carolina.
- Diovan treats high blood pressure and heart failure; doctors generally advise against stopping a blood-pressure medication abruptly, even a recalled one, without medical guidance.
Novartis has recalled a single nationwide lot of its blood pressure drug Diovan (valsartan) 160 mg tablets after the batch failed dissolution testing, meaning the tablets may not break down properly in the body and could deliver less of the drug than intended. The FDA classified the recall Class II on August 7, a mid-tier severity that covers products where exposure may cause temporary or medically reversible health effects.
What's being recalled
- Diovan (valsartan) 160 mg tablets, 90-tablet bottles
- Lot number AV5913C, expiration 06/2027
- Manufactured by Patheon Manufacturing Services in North Carolina; distributed by Novartis
- Recall initiated by Novartis on August 4, 2026; FDA classified it Class II on August 7
What the defect means
Valsartan is an angiotensin II receptor blocker used to treat high blood pressure, heart failure, and left ventricular dysfunction following a heart attack — it works, per Mayo Clinic, by blocking a substance in the body that causes blood vessels to tighten. A dissolution failure means the tablets may not dissolve as designed, which can affect how much of the drug actually reaches the bloodstream. That's a functional problem, not a contamination one, but it still means patients on the affected lot may not be getting a fully effective dose.
Sources
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