Valsartan Tablets Recalled Due to Failed Dissolution Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Diovan (valsartan) tablets, 160 mg. The affected batch has been identified as Lot AV5913C (expires June 2027).
• The recall was initiated by Novartis Pharmaceuticals due to failed dissolution specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Valsartan is used to treat hypertension as well as heart failure and left ventricular failure.

The FDA has issued a Class II recall for Diovan (valsartan) tablets, 160 mg. This product is manufactured by Patheon Manufacturing Services, LLC in North Carolina and is being recalled by Novartis Pharmaceuticals based in East Hanover, New Jersey. The recall was initiated on August 4, 2026, and received a Class II classification on August 7, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product's failure to meet dissolution specifications. This deficiency affects Lot AV5913C, which will expire in June 2027. Novartis Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.

Valsartan is a prescription medication used to treat high blood pressure. It can also be used to treat heart failure or left ventricular heart failure and improve survival after a heart attack. Pharmacists should identify and quarantine Lot AV5913C, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 19, 2026. Accessed August 19, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221863