Life sciences · Safety recall

Class II recall: Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutic

U.S. Food and Drug Administration · August 19, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA issued a Class II recall of Diovan (valsartan) 160 mg tablets manufactured by Patheon Manufacturing Services LLC and distributed by Novartis Pharmaceuticals, initiated voluntarily by the firm. The recall was triggered by failure to meet dissolution specifications, a manufacturing quality defect that may compromise drug bioavailability. This is a regulatory safety action addressing product quality; it does not report clinical trial results or patient outcomes.

What was studied

Safety recall. Patients who received Diovan (valsartan) 160 mg tablets, 90-tablet bottles, distributed nationwide in the United States. Manufacturing: Greenville, NC; Distribution: East Hanover, NJ; Recall distribution: US Nationwide.

Key findings

Diovan (valsartan) 160 mg, 90-tablet bottles recalled due to failed dissolution specifications Recall is Class II and ongoing Initiated voluntarily by Novartis Pharmaceuticals Corporation

Safety

This record does not contain clinical trial results, efficacy data, or adverse event reports. Initiated voluntarily by Novartis Pharmaceuticals Corporation

Who this may help

Patients taking affected lots may experience subtherapeutic drug levels due to failed dissolution, potentially compromising blood pressure control. Prescribers should verify lot numbers and counsel affected patients; the FDA and Novartis will provide guidance on product replacement or verification.

Plain-language summary

FDA Class II recall of valsartan 160 mg due to failed dissolution specifications; affects product quality and bioavailability but does not report clinical trial outcomes.

Study design

As stated by the source record.

SettingManufacturing: Greenville, NC; Distribution: East Hanover, NJ; Recall distribution: US Nationwide

Reported figures

Quoted from the source exactly as published.

Recall classificationClass II

Recall statusOngoing

Product dose and package size160 mg, 90 tablets

NDC0078-0359-34

Geographic distributionUS Nationwide

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or adverse event reports.
Specific lot numbers and distribution dates are not provided in this record.
No data on the number of units distributed or recalled are reported.
The clinical impact of failed dissolution on individual patients or population outcomes is not quantified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory action, not a clinical study.

Directness

insufficient

Recall addresses manufacturing defect; no clinical efficacy or safety data provided.

Consistency

insufficient

Single regulatory action; no comparative or replicated data reported.

Risk of bias

insufficient

Not applicable to regulatory enforcement action.

Sample adequacy

insufficient

No patient cohort or sample size; manufacturing and distribution scope only.

Source abstract

FDA enforcement report D-0746-2026. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Novartis Pharmaceuticals Corporation. Initiated as: Voluntary: Firm initiated. 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 for recall: Failed Dissolution Specifications Distribution: US Nationwide

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Novartis Pharmaceuticals