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IT ATC R03DC03 · updated 2 Nov 2026

Montelukast shortage in Italy

Is there a Montelukast shortage in Italy?

Yes. As of 2 Nov 2026, 4 Montelukast products are reported short in Italy, the first since 1 May 2024. No return date has been given. Main reason: manufacturing problem.

Also short in United States, Canada, France, Spain, Ireland, Austria, Belgium, Czechia, Norway, Sweden, Japan, New Zealand. All countries.

Affected products in Italy

CountryProductCompanySinceExpected backReason
ITSASLONGSO.SE.PHARM S.R.L. SOCIETA' DI SERVIZIO PER L'INDUSTRIA FARMACEUTICA ED AFFINI1 May 2024not givenManufacturing problem
Problemi produttivi
ITMONTELUKAST ACCORDACCORD HEALTHCARE, S.L.U.27 Feb 2026not givenIncreased demand
Elevata richiesta
ITMONTELUKAST MYLAN GENERICS anticipatedMYLAN S.P.A.7 Nov 2026not givenManufacturing problem
Problemi produttivi
ITMONTELUKAST AUROBINDO anticipatedAUROBINDO PHARMA (ITALIA) S.R.L.22 Dec 2026not givenManufacturing problem
Problemi produttivi

Source

AIFA (Italian Medicines Agency), licensed CC-BY 4.0. Official list. All shortages reported by marketing-authorisation holders, including medicines being withdrawn.