Novartis Recalls Diovan 160mg Tablets Due to Failed Dissolution Specifications
Novartis recalls Diovan 160mg tablets (NDC 0078-0359-34) manufactured by Patheon in Greenville, NC with lot AV5913C. Failed dissolution specifications may affect drug effectiveness.
Lower-risk recall
Failed Dissolution Specifications
What happened, in plain English
Novartis is recalling Diovan 160mg tablets that may not dissolve properly as tested. This could mean the medication isn't working as intended for people taking it by prescription. Read more at govinfonow.com/recall/454398-novartis-recalls-diovan-160mg-tablets-due-to-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/454398-novartis-recalls-diovan-160mg-tablets-due-to-failed-dissolution-specifications · Updated August 27, 2026 · FDA enforcement record: FDA #D-0746-2026
Cite this page
“Novartis Recalls Diovan 160mg Tablets Due to Failed Dissolution Specifications.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/454398-novartis-recalls-diovan-160mg-tablets-due-to-failed-dissolution-specifications. Based on FDA recall #D-0746-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0746-2026%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications during testing, meaning they might not dissolve properly in the body. This could lead to the medication not working as intended, potentially affecting blood pressure control for patients.
Who’s affected
People with a prescription for Diovan 160mg tablets (90 tablets) manufactured by Patheon in Greenville, NC with lot number AV5913C. Those who have taken the medication recently may be at risk of ineffective treatment.
How to tell if you have this one
Check for the product name 'Diovan', strength 160mg, 90 tablets, prescription-only, manufactured by Patheon in Greenville, NC, lot number AV5913C, with expiry date 6/2027.
- Brand
Novartis- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Diovan tablets match the recalled specifications: 160mg, 90 tablets, prescription-only, Patheon Manufacturing Services LLC, Greenville, NC, lot AV5913C.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall is for potential ineffective medication, not a safety hazard. The risk is low as the tablets may not dissolve properly, but this does not cause injury.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0746-2026 (August 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0746-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.