CLASS II ONGOING Drug recall · Reported 19 Aug 2026 · FDA Enforcement Report
Diovan (valsartan) 160 mg recalled by Novartis Pharmaceuticals
Novartis Pharmaceuticals is recalling Diovan (valsartan) 160 mg, distributed nationwide in the US. The recall was initiated on 4 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0746-2026
- FDA event ID
- 99552
- Recalling firm
- Novartis Pharmaceuticals, East Hanover, NJ
- Brand
- Diovan
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Aug 2026
- FDA classified
- 7 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 4 Aug 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +3 days |
| 19 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot AV5913C, Expiry: 6/2027
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novartis Pharmaceuticals
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalledXiidra | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalled | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
Other Valsartan recalls
All 88| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Valsartan Tablets recalled by Cardinal HealthValsartan | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets 80 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |