Novartis Pharmaceuticals recall: Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing…
Novartis Pharmaceuticals Corporation is recalling Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing…. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on August 4, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

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| Product | Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing… |
| Brand | Novartis Pharmaceuticals |
| Company | Novartis Pharmaceuticals Corporation |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 4, 2026 |
| Published by FDA | August 19, 2026 |
| Recall ID | 99552 |
Recalled products
- 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
- FDA recall number
- D-0746-2026
- Codes, lots and dates
- Lot AV5913C, Expiry: 6/2027
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99552
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- East Hanover, NJ, United States
Why it was recalled
The reason the FDA lists: “Failed Dissolution Specifications”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99552, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Failed Dissolution Specifications: below specification Serious | FDA Class II | |
| Oct 7, 2026 | Crystallization Serious | FDA Class II | |
| Oct 7, 2026 | Failed dissolution specifications. Serious | FDA Class II | |
| Oct 7, 2026 | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II | |
| Oct 7, 2026 | a sterility problem Serious | FDA Class II | |
| Oct 7, 2026 | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Novartis Pharmaceuticals Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing… recalled?
Yes. Novartis Pharmaceuticals Corporation recalled it on August 4, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Dissolution Specifications
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.