Novartis Recalls Diovan Valsartan Tablets Due to Failed Dissolution Specifications
Novartis is recalling specific lots of Diovan (valsartan) 160 mg tablets because they failed to meet required dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves failed dissolution specifications without reported illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling Diovan (valsartan) 160 mg tablets, 90-count bottles, due to failed dissolution specifications. The affected product is identified by Lot AV5913C with an expiration date of 6/2027. The medication was manufactured by Patheon Manufacturing Services LLC in Greenville, NC, and distributed by Novartis Pharmaceutical Corp in East Hanover, NJ.
The recall is limited to the specific lot and NDC 0078-0359-34. The source text does not provide information regarding the number of units affected, specific distribution locations beyond the manufacturer and distributor addresses, or any reported adverse health events. The hazard is that the tablets may not dissolve as required, which could affect the delivery of the medication.
Patients and healthcare providers should check their medication for the specific lot number AV5913C and expiration date of 6/2027. If the medication matches these details, it should not be used. Patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options or replacement medication.
The recalled product
- Product
- DIOVAN (VALSARTAN)
- Brand
- DIOVAN
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot AV5913C
- Expiry: 6/2027
Distribution
Distributed nationwide across the United States.
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