Quality & complianceOfficial

SÚKL orders Nitromint batch recall down to healthcare facility level in Czechia

🇨🇿 SÚKL · Fri 30 Oct 2026

Czech regulator SÚKL has told distributors and healthcare facilities to withdraw a specified batch of Nitromint 2.6 mg modified-release tablets; patients need not return packs.

The Czech State Institute for Drug Control (SÚKL) announced on 30 October 2026 that a specified batch of Nitromint (nitroglycerin) 2.6 mg modified-release tablets, pack of 60, is to be recalled. The withdrawal extends down to the level of healthcare facilities.

The notice comes from SÚKL's quality defects department and is addressed to distributors and healthcare facilities. They are expected to pull the affected stock. The published text does not give the batch number, the nature of the quality defect or the reason for the recall, and these details are not stated in the item.

Patients are not required to return packs they already hold, according to SÚKL. The regulator's communication is available as a PDF dated 30 October 2026.

SÚKL's page also lists a related notice from 29 August 2025, which likewise concerned the withdrawal of a specified batch of Nitromint 2.6 mg modified-release tablets, pack of 60, down to healthcare facility level. The source does not say whether the two recalls are connected.

What it means for your team

  • Distributors and healthcare facilities in Czechia should check stock against the batch identified in the SÚKL communication and quarantine and withdraw any affected packs.
  • Quality teams should obtain the PDF notice for the batch details, as the web summary does not name the batch or the defect.
  • No patient-level recall is required, so patient communication is unlikely to be needed for returns, according to SÚKL's instruction.
  • Teams tracking Nitromint should note the earlier August 2025 recall of a batch of the same product and pack, though no link is established in the source.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

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