Quality & complianceOfficial

SÚKL warns of falsified Mounjaro batches found in Brazil; none identified in Czech Republic

🇨🇿 SÚKL · Sat 07 Nov 2026

The Czech medicines authority says counterfeit Mounjaro detected abroad has not been traced in the Czech market, and asks operators to report any sighting of the listed batches immediately.

SÚKL, the Czech State Institute for Drug Control, published a notice on 7 November 2026 about falsified Mounjaro that has surfaced outside the country. The authority states that the affected batches have not been detected in the Czech Republic.

The information came from the Brazilian regulator, which told SÚKL about counterfeit Mounjaro in strengths of 2.5 mg, 5 mg and 15 mg. The batch numbers listed are KUSTR43969410, B55010, D810042, D838889 and 2138737, all carrying an expiry date of 06/2028. According to SÚKL, the fakes were probably seized in Brazil.

In the Czech Republic, Mounjaro solution for injection is authorised through the national procedure. SÚKL checked the batches against the regular reports on distributed medicines and found that none of them had been supplied to the Czech market. The marketing authorisation holder has confirmed that the batch numbers are not genuine ones.

SÚKL asks all operators to tell it without delay if they come across any of the listed batches. 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, returns and incoming consignments against the five listed batch numbers; the notice is precautionary, as no match has been found in Czech distribution data.
  • Any sighting of these batches should go straight to SÚKL via the phone number or email given in the notice.
  • The marketing authorisation holder says these batch numbers are not original, so a match would point to a falsified product rather than a quality defect.
  • Supply-chain and falsified-medicines teams may wish to record the alert in their monitoring of information shared between regulators.

Official source: SÚKL ↗

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

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