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Class II: temporary or reversible health riskOngoing

Novartis Pharmaceuticals Diovan Recall

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing…

Novartis Pharmaceuticals Corporation · East Hanover, NJ

Risk level
Class II
Reported by FDA
Aug 19, 2026
Recall ID
D-0746-2026
Check your lot numberHow we source this data

Summary

Novartis Pharmaceuticals recalled Diovan starting Aug 4, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0746-2026 on Aug 19, 2026. Reason: Failed Dissolution Specifications. Status: Ongoing.

Why it was recalled

Failed Dissolution Specifications

Product description

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

Lot numbers, UPCs & expiration codes

Lot AV5913C, Expiry: 6/2027

Where it was sold

US Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0746-2026
Classification
Class II
Status
Ongoing
Recall initiated
Aug 4, 2026
FDA report date
Aug 19, 2026
Recall type
Voluntary: Firm initiated
Recalling firm
Novartis Pharmaceuticals Corporation

Original FDA data

Every field from FDA enforcement report D-0746-2026, exactly as published.

Show all FDA fields
City
East Hanover
State
NJ
Status
Ongoing
Country
United States
Event ID
99552
Address
1 Health Plz
Code information
Lot AV5913C, Expiry: 6/2027
Postal code
07936-1016
Report date
Aug 19, 2026
Product type
Drugs
Recall number
D-0746-2026
Classification
Class II
Recalling firm
Novartis Pharmaceuticals Corporation
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
US Nationwide
Recall initiation date
Aug 4, 2026
Initial firm notification
Letter
Center classification date
Aug 7, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0746-2026, published Aug 19, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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