Diovan (Valsartan) Recall Issued for Failed Dissolution

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Novartis Pharmaceuticals Corporation is voluntarily recalling one lot of Diovan (valsartan) 160 mg tablets due to failed dissolution specifications.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 25, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.

What Happened

Novartis Pharmaceuticals Corporation initiated a voluntary recall due to failed dissolution specifications.

Which Products Are Affected

Diovan (valsartan) 160 mg, 90 tablets, Rx only, NDC 0078-0359-34, Lot AV5913C, Expiry: 6/2027. Manufactured by Patheon Manufacturing Services LLC and distributed by Novartis Pharmaceutical Corp, East Hanover, NJ. Distributed nationwide in the United States. Recall number D-0746-2026.

What You Should Do

Consumers with questions should contact their pharmacist or healthcare provider. The recall is ongoing and was classified as Class II.

Why This Matters

The recall affects prescription medication distributed across the United States and involves a manufacturing specification failure.

Source

FDA recall D-0746-2026; event ID 99552.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Novartis Pharmaceuticals Corporation is voluntarily recalling one lot of Diovan (valsartan) 160 mg tablets due to failed dissolution specifications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.