FDA recall, , Moderate risk
Novartis Diovan Tablets
Diovan (valsartan) 160 mg tablets failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
Novartis Pharmaceuticals Corporation recalled Diovan (valsartan) 160 mg, 90 tablets, Rx only, manufactured by Patheon Manufacturing Services LLC, Greenville, NC 27834, and distributed by Novartis Pharmaceutical Corp, East Hanover, NJ 07936, because the product failed dissolution specifications. The recall began August 4, 2026, and was added to the FDA's Enforcement Report on August 7, 2026. The product was distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Diovan (valsartan) 160 mg, 90 tablets
- NDC
- 0078-0359-34
- Lot code
- AV5913C
Recall details
- Company began the recall
- Sold in
US Nationwide
- Company
- Novartis Pharmaceuticals CorporationEast Hanover, New Jersey
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99552
- Recall number
- D-0746-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
