Class IIDrug
Diovan recall
Summary
Novartis Pharmaceuticals Corporation is recalling Diovan (valsartan) 160 mg (drug). According to the FDA report, the reason is: Failed Dissolution Specifications. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Failed Dissolution Specifications
- Lot / code info
- Lot AV5913C, Expiry: 6/2027
- Quantity
- Not listed
- Distribution
- US Nationwide
- Recalling company
- Novartis Pharmaceuticals Corporation, East Hanover, NJ United States
- Recall started
- August 4, 2026
- FDA report date
- August 19, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0746-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Novartis Pharmaceuticals Corporation) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.