Quality & complianceOfficial

SÚKL orders recall of Betadine 100 mg/g ointment batch to healthcare-facility level

🇨🇿 SÚKL · Fri 30 Oct 2026

The Czech regulator has told distributors and healthcare facilities to withdraw a specified batch of Betadine 30 g ointment; patients are not asked to return packs.

The Czech State Institute for Drug Control (SÚKL) announced on 30 October 2026 that a specified batch of Betadine 100 mg/g ointment, in 30 g packs, is being withdrawn from the market. The notice came from the agency's quality defects department.

The recall is to be carried out down to the level of healthcare facilities. SÚKL addressed the notice to distributors and healthcare facilities, which are expected to carry out the withdrawal of the affected batch.

Patients are not asked to return their packs, according to the notice. The regulator published the communication as a PDF dated 30 October 2026.

The text available to VigiEye does not give the batch number or the reason for the recall. Those details may be in the linked PDF, which was not part of the material reviewed. Readers should check the original SÚKL communication before acting.

What it means for your team

  • Distributors and healthcare facilities in the Czech Republic should consult the SÚKL PDF for the batch identification and apply the withdrawal to stock held.
  • Because patients are not asked to return packs, the recall is aimed at the supply chain and facility stock rather than at consumers.
  • Quality and regulatory teams should note that the batch number and defect reason are not stated in the web notice, so the PDF is the key source for both.

Official source: SÚKL ↗

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

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