FDAFDA recall D-0746-2026 · Aug 19, 2026
Novartis Pharmaceuticals Corporation: Diovan (valsartan) 160 mg recall
Recall found
Product
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
Reason for recall
Failed Dissolution Specifications
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot AV5913C, Expiry: 6/2027
- Distribution
- US Nationwide
- Recalling firm
- Novartis Pharmaceuticals Corporation, East Hanover, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-04
Source: openFDA enforcement record D-0746-2026 · search recall number D-0746-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.