PMDA posts N-nitroso-meglumine findings for three telmisartan tablet lines
Sandoz, Meiji and VTRS tablet notices report levels up to 2.7 times the usual daily intake limit, but below the interim control value.
On 5 November 2026, Japan's PMDA posted November notices from three groups of manufacturers and distributors concerning telmisartan 20, 40 and 80 mg tablets marketed as Sandoz, Meiji and VTRS. Their self-inspections detected N-nitroso-meglumine. These are product-specific quality notices, not a new statutory limit or analytical method.
All three notices report detected levels up to 2.7 times the European authority's acceptable daily intake of 100 ng/day, but below the temporary control value of 670 ng/day used during impurity-reduction measures. The companies state that their health-risk assessments do not call for immediate recall or stopping prescriptions; patients should not stop treatment on their own.
Quality-control laboratories working on the affected products should reconcile product and batch scope, target impurity, applicable control values and reduction plans against current manufacturer information. The public notices do not provide detailed analytical methods or batch-level results, so those conditions must not be inferred. The interim value must be distinguished from the usual acceptable daily intake.