Quality & complianceOfficial

Czech regulator warns of counterfeit Mounjaro batches found in Brazil, none detected in Czechia

🇨🇿 SÚKL · Sat 07 Nov 2026

SÚKL says falsified Mounjaro (tirzepatide) batches reported by Brazil's regulator have not been identified in the Czech market, and has asked operators to report any sighting immediately.

The Czech State Institute for Drug Control (SÚKL) has issued a notice on counterfeit Mounjaro detected abroad. Its quality defects department said the affected batches have not been found in the Czech Republic.

SÚKL was informed by Brazil's regulatory authority about falsified Mounjaro in 2.5 mg, 5 mg and 15 mg strengths. The batch numbers listed are KUSTR43969410, B55010, D810042, D838889 and 2138737, all bearing an expiry date of 06/2028. The counterfeits were probably seized in Brazil.

Mounjaro solution for injection is authorised in the Czech Republic through the national procedure. SÚKL checked the batch numbers against its regular reports on distributed supplies and found that none of them had been delivered to the Czech market. The marketing authorisation holder also confirmed that these are not genuine batch numbers.

SÚKL has asked all operators to pass on any information without delay if they come across the listed batches of Mounjaro. Reports can be made by telephone on +420 272 185 363 or by email to zavady@sukl.gov.cz.

What it means for your team

  • Check stock and incoming consignments against the five listed batch numbers (expiry 06/2028), including any parallel or non-standard supply routes.
  • Any match should be reported to SÚKL immediately by phone or email, in line with falsified-medicines procedures.
  • Update quarantine and escalation procedures for suspected falsified GLP-1/GIP products, and brief warehouse and pharmacy staff.
  • No Czech market impact has been identified so far, so no recall or supply action is indicated by the notice.

Official source: SÚKL ↗

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

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