Diovan (valsartan) 160 mg recall
FDA recall D-0746-2026 · initiated Aug 4, 2026
Novartis Pharmaceuticals Corporation recalled Diovan (valsartan) 160 mg in Aug 2026 — an FDA Class II recall (D-0746-2026) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- Novartis Pharm
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide
- Initiated
- Aug 4, 2026
- FDA report date
- Aug 19, 2026
Frequently asked
- Was Diovan (valsartan) 160 mg recalled?
- Novartis Pharmaceuticals Corporation recalled Diovan (valsartan) 160 mg in Aug 2026 — an FDA Class II recall (D-0746-2026) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Diovan (valsartan) 160 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0746-2026 was: Failed Dissolution Specifications
- Is a recalled Diovan (valsartan) 160 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Diovan (valsartan) 160 mg are affected?
- Distributed: US Nationwide. The recall covers these lots — Lot AV5913C, Expiry: 6/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0746-2026.