oAlert.pl

Recalled Medicines & supplements – Current GIS Alerts 2026

Found 698 recalled products in the Medicines & supplements category. Check batch numbers, shops, and hazard information.

Common hazards in this category

All recalled products

Konaten – recalled product

Konaten

MEDIUM 28.08.2024

Out-of-specification (OOS) results were found for atomoxetine content (below the lower limit) and, for one batch, failure in capsule mass uniformity, which may lead to administration of too low a dose of the active substance. Potential effects: reduced treatment efficacy, possible worsening of disease symptoms.

Konaten – recalled product

Konaten

MEDIUM 28.08.2024

Out-of-specification results were found for atomoxetine content, below the lower specification limit, and for one batch non‑compliant capsule mass uniformity; the risk assessment indicated mainly potentially reduced drug efficacy. Potential effects: lack of or reduced treatment effectiveness.

Konaten – recalled product

Konaten

MEDIUM 28.08.2024

Out-of-specification results were found in reference samples for atomoxetine content (outside the 95.0–105.0% range) and, in one case, for capsule mass, indicating variable active substance dosage. Potential effects: reduced treatment effectiveness or increased adverse reactions.

Konaten – recalled product

Konaten

MEDIUM 28.08.2024

Out-of-specification (OOS) results were found in reference samples for atomoxetine content, below the lower specification limit; for one batch also non-compliance in capsule mass uniformity; the impact on safety was assessed as low. Potential effects: reduced treatment effectiveness, possible worsening of symptoms, risk of complications due to poor disease control.

Monover – recalled product

Monover

CRITICAL 22.08.2024

A clearly visible large piece of glass (about 1 cm) was found moving inside the vial, as well as glass particles on the walls and neck of the vial of a product administered intravenously. Potential effects: severe vascular complications, embolism, tissue damage, life‑threatening complications.

Eptifab – recalled product

Eptifab

CRITICAL 16.08.2024

An incorrect dosing regimen for the medicinal product in solution for injection form, resulting from erroneous leaflet data, may cause direct adverse health consequences for patients, posing a real risk to health and potentially to life. Potential effects: overdose or insufficient efficacy, serious cardiovascular complications, life‑threatening events.

Gripblocker Express – recalled product

Gripblocker Express

MEDIUM 14.08.2024

A quality defect was found: cracking of the soft gelatin capsule seam and leakage of the fill into the blister pocket, risking intake of an incomplete dose and lack of therapeutic effectiveness. Potential effects: lack of efficacy, persistence or worsening of symptoms.

Acurenal – recalled product

Acurenal

CRITICAL 09.08.2024

Stability testing and reference sample results showed that the batches covered by the decision do not meet the requirement for the parameter "Purity: content of impurity A", which constitutes a real and direct risk to patients' health or life. Potential effects: poisoning, lack of treatment efficacy, increased adverse effects.

Atofab – recalled product

Atofab

MEDIUM 09.08.2024

Out-of-specification results were found for atomoxetine content and non-uniform capsule mass in batches manufactured from the same bulk batches; risk assessment indicates possible reduced therapeutic efficacy. Potential effects: possible treatment failure and worsening of disease symptoms.

Acurenal – recalled product

Acurenal

MEDIUM 09.08.2024

It was determined that batches 80219782 and 80212781 do not meet the requirements for the parameter “Purity: content of impurity A”, and exceeding the acceptance criteria was considered a real and direct threat to patients’ health or life. Potential effects: possible adverse effects, poisoning, lack of treatment safety.

Atofab – recalled product

Atofab

MEDIUM 09.08.2024

Out-of-specification (OOS) results were found in reference samples for the atomoxetine content parameter, which may affect the quality and effectiveness of the medicine. Potential effects: lack or reduced treatment efficacy, possible worsening of disease symptom control.

Osporil – recalled product

Osporil

CRITICAL 05.08.2024

The National Medicines Institute found in batch ZD033 the presence of particles visible to the naked eye in a solution administered by intravenous infusion; any exceedance of quality criteria constitutes a real and direct threat to patients' health or life. Potential effects: embolic complications, inflammatory reactions, life-threatening events.

Viglita – recalled product

Viglita

MEDIUM 01.08.2024

This product did not meet its defined quality requirements due to a negative test result for the friability of uncoated tablets ("tablets crumbled after the test"). Potential effects: possible problems with dosing and treatment effectiveness.

Qutiro – recalled product

Qutiro

CRITICAL 23.07.2024

In five patients after infusion of the product, chills and chest pain occurred and blood cultures grew Klebsiella pneumoniae ESBL; in another three patients, chills progressed to generalized convulsions. A real threat to patients’ health or life was indicated. Potential effects: severe bloodstream infection, septic complications, life‑threatening condition.

Qutiro – recalled product

Qutiro

CRITICAL 23.07.2024

In patients after infusion of the product, chills, chest pain and generalized convulsions occurred; blood cultures grew Klebsiella pneumoniae ESBL, and the inspector indicated a real threat to patients’ health or life. Potential effects: severe bloodstream infections, septic shock, life‑threatening conditions.

Konaten – recalled product

Konaten

LOW 17.07.2024

Out-of-specification (OOS) results were found for atomoxetine content in reference samples of several batches and a failure in the capsule mass uniformity parameter, caused among others by loss of active substance during filling and lack of full capsule weight control. Potential effects: reduced treatment effectiveness, possible worsening of disease symptoms.

Konaten – recalled product

Konaten

MEDIUM 17.07.2024

In reference samples, out-of-specification (OOS) results were found for atomoxetine content, and for batch 1304011 also for capsule mass uniformity, which may affect dosing. Potential effects: reduced treatment efficacy or adverse reactions due to incorrect dose.

Konaten – recalled product

Konaten

MEDIUM 17.07.2024

Out-of-specification (OOS) results were found in retention samples for atomoxetine content and, for batch 1304011, also for mass uniformity; the impact of this non‑conformity on the drug’s efficacy and safety cannot be determined. Potential effects: reduced treatment efficacy or unpredictable adverse effects.

Paracetamol Aflofarm – recalled product

Paracetamol Aflofarm

HIGH 10.07.2024

Tests showed that despite shaking, sediment remains at the bottom of the bottle and some doses contain paracetamol outside the specification (e.g. 141.2 mg/5 ml with a limit of 114.0–126.0 mg/5 ml). Potential effects: risk of paracetamol overdose or incorrect treatment efficacy.

Palifren Long – recalled product

Palifren Long

CRITICAL 01.07.2024

A justified suspicion of a quality defect of the medicinal product was identified, and its occurrence was subsequently confirmed in batches 4201120, 4300099 and 4201591. The nature of the defect is not specified in the decision. Potential effects: possible treatment complications, lack of efficacy or adverse reactions.

What to do if you bought a recalled product?

If you have purchased any of the products listed above, stop using or consuming them immediately. You can return the product to the store where you bought it for a full refund. Keep the receipt if possible, but most stores will accept returns even without one.