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[SITUATION] · [ACTIVE] · [HEALTH]

2 clusters · 11 sources · 15 days · First seen 17 days ago · Last updated 2 days ago

Antidepressant drug recalls in Poland

Overview

In late August 2026, the Chief Pharmaceutical Inspector (GIF) in Poland issued a nationwide recall and temporary market ban on several formats of the antidepressant Dutilox (Duloxetinum). The recall, affecting 30 mg and 60 mg hard gastrointestinal capsules, was prompted by the detection of N-nitroso-duloxetine contamination exceeding acceptable thresholds, posing a potential public health risk.

In September 2026, the Inspectorate issued another recall in Poland, this time for a specific batch of the antidepressant Fluoxetine EGIS (10 mg, 28-count packs). This action followed stability studies showing active ingredient levels below required specifications. While the manufacturer, Egis Pharmaceuticals PLC, attributed the issue to a localized filling error and argued the variations were clinically insignificant, the regulator maintained that the product must meet quality specifications in its entirety to ensure efficacy.

Entities

Chief Pharmaceutical Inspectorate · Główny Inspektor Farmaceutyczny · Farmak International Sp. z o. o. · Dutilox · Poland

Timeline

2 days ago

[HEALTH] 7 sources
Fluoxetine EGIS antidepressant recalled in Poland
The Polish Chief Pharmaceutical Inspectorate has recalled batch 4914A0125 of Fluoxetine EGIS (10 mg) due to insufficient active ingredient levels found during stability testing.
17 days ago

[HEALTH] 9 sources
Dutilox antidepressant recalled in Poland due to contamination
Poland's Chief Pharmaceutical Inspector has recalled all series of Dutilox (Duloxetinum) 30 mg and 60 mg capsules due to dangerous levels of N-nitroso-duloxetine contamination.

Sources

fakt.pl · krotoszynska.pl · medonet.pl · moj.powiat.pl · opieka.farm · punjabilok.com · rynekzdrowia.pl · superbiz.se.pl · zdrowie.co.pl · zdrowie.wprost.pl · zpleszewa.pl