[CLSTR]
< Back to situation

[REVISION HISTORY]

Poland drug safety bans and recalls

Updated 1 time since CLSTR started tracking revisions of this situation.

What changed

2026-07-31 15:47 UTC → 2026-08-02 12:53 UTC · added removed

Poland drug recall actions safety bans and recalls

In late July 2026 Poland’s chief drug regulator, the Główny Inspektorat Farmaceutyczny (GIF), ordered a nationwide withdrawal of Concor 5 mg and Concor Cor 5 mg hypertension tablets after testing identified nitrosamine N‑Nitroso‑Bisoprolol (NBP) above the permissible limit. The contamination was traced to specific batches produced between November 2022 and September 2023 by Merck and to parallel‑imported batches from Bulgaria and Spain, with the auxiliary substance supplier excluded from production. Patients were instructed to stop using the tablets and return them for replacement. A week later, later GIF issued a second urgent recall, this time of Adnamil 300 mg allopurinol tablets used for gout and kidney stones. The recall targeted a single batch from Polfarmex S.A. after inspection revealed a white powdery coating, tablet damage, and excessive resistance to crushing, raising concerns about the drug’s release and safety. Distribution of the batch was banned across Poland. Both actions illustrate On 31 July 2026 the regulator’s rapid response to distinct quality regulator expanded its actions, prohibiting the introduction of Atorvastatin Medical Valley tablets across all series because coating defects could compromise stability and safety issues efficacy, and reaffirming the withdrawal of the contaminated Concor batches. In the same announcement the national sanitary inspection warned of Listeria monocytogenes in different medication classes, emphasizing heightened vigilance over pharmaceutical products on a batch of raw sausage, and the Polish market. Ministry of Health reported that the anti‑export list now covers 288 medicines, about 1.6 % of authorized products.

Versions

  1. 2026-08-02 12:53 UTC Poland drug safety bans and recalls
  2. 2026-07-31 15:47 UTC Poland drug recall actions

Only revisions since CLSTR began indexing content versions appear here. Select a version to see what changed compared to the one before it.