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Medicines & supplements – Current GIS Alerts 2026

Found 734 alerts in the Medicines & supplements category. Check batch numbers, shops, and hazard information.

Common hazards in this category

All recalled products

Recalled product: Carmustine Accord

Carmustine Accord

GIF Critical 23.12.2025

The solvent component of the medicine does not meet quality requirements due to a negative test result for the "residue on evaporation" parameter, with a value several times above the acceptable limit. Potential effects: poisoning, toxic effects, complications after intravenous administration.

Recalled product: Egoropal

Egoropal

GIF Critical 23.12.2025

A routine FDA inspection revealed serious deficiencies in aseptic manufacturing processes; the assessed risk to product quality and patient safety for aseptically filled batches on the market is high. The product is a parenteral solution for injection. Potential effects: infections after parenteral administration, severe complications, lack of treatment safety.

Recalled product: Egoropal

Egoropal

GIF Critical 23.12.2025

A routine FDA inspection revealed serious deficiencies in aseptic manufacturing processes. The risk assessment indicated a high risk to product quality and patient safety for aseptically filled batches available on the market. Potential effects: infection, sepsis, serious complications, lack of treatment efficacy.

Recalled product: Palifren Long

Palifren Long

GIF Critical 23.12.2025

An FDA inspection at the manufacturer revealed non-compliance in sterile/aseptic processing and procedures, indicating a threat to the quality of these medicinal products and forming the basis for their withdrawal from the market. Potential effects: infection, poisoning, severe complications after injection.

Recalled product: Palifren Long

Palifren Long

GIF Critical 23.12.2025

The inspection revealed non-compliances in sterile/aseptic processing and procedures, indicating a risk to the quality of the medicinal products. Potential effects: infection, sepsis, loss of sterility of a parenterally administered product.

Recalled product: Palifren Long

Palifren Long

GIF Critical 23.12.2025

An FDA inspection at the manufacturer found non-compliances in sterile/aseptic processing and procedures. Deviations in sterile manufacturing were detected, posing a risk to the quality of these medicinal products. Potential effects: infection after injection, poisoning, severe systemic complications.

Recalled product: Palifren Long

Palifren Long

GIF Critical 23.12.2025

An FDA inspection at the manufacturer revealed non-compliances in sterile/aseptic processing and procedures, posing a risk to the quality and sterility of Palifren Long prolonged-release injectable suspension products. Potential effects: infection after injection, severe systemic complications, lack of treatment safety.

Recalled product: Clarithromycin Adamed

Clarithromycin Adamed

GIF Critical 19.12.2025

Falsification of the active substance Clarithromycin and lack of confirmation that quality requirements for the key component of this parenteral product (solution for infusion) are met have been identified, so a risk to patients' health or life cannot be excluded. Potential effects: lack of treatment efficacy, unpredictable adverse reactions, severe life-threatening complications.

Recalled product: Clarithromycin hameln

Clarithromycin hameln

GIF Critical 18.12.2025

Lack of confirmed quality of the active substance used for batch 25D052 and non-compliance with GMP requirements in the supply chain. The product is a solution for infusion, so potential quality deviations carry an increased risk to patients' health and life. Potential effects: poisoning, lack of efficacy, complications during intravenous therapy.

Recalled product: Lorafen

Lorafen

GIF High 17.12.2025

An out-of-specification result was found in long-term stability testing (parameter: active substance release below the lower acceptance limit), which constitutes a real and direct threat to patients' health or life. Potential effects: reduced treatment efficacy, disease exacerbation, complications endangering health or life.

Recalled product: Itami

Itami

GIF Medium 12.12.2025

The identified quality defect is insufficient adhesion of the patch to the skin; the patch does not remain firmly attached, preventing the product from fulfilling its intended therapeutic function. Potencjalne skutki: lack of treatment efficacy, possible recurrence or worsening of symptoms.

Recalled product: PHELINUN

PHELINUN

GIF High 11.12.2025

The identified discrepancy in the incorrectly described label on the vial with powder may pose a risk of incorrect preparation of the medicine, and thus a health risk to patients cannot be excluded. Potencjalne skutki: lack of treatment efficacy or complications related to an inappropriate dose of cytostatic drug.

Recalled product: Vitamina C Synteza

Vitamina C Synteza

GIF Medium 09.12.2025

Brown spots were found on the capsules, which means non-compliance with quality requirements for the external appearance parameter; the authority decided that a risk to patients’ health cannot be excluded. Potential effects: potentially reduced medicine quality, lack of efficacy or unforeseen reactions.

Recalled product: Varilrix, Live varicella vaccine, Powder and solvent for solution for injection, not less than 10^3.3 PFU of varicella virus, Oka strain/0.5 ml; 1 dose (0.5 ml)

Varilrix, Live varicella vaccine, Powder and solvent for solution for injection, not less than 10^3.3 PFU of varicella virus, Oka strain/0.5 ml; 1 dose (0.5 ml)

GIF Critical 04.12.2025

The reported signal concerned the occurrence of a serious adverse reaction related to the medicinal product and was assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA). Potential effects: serious adverse reactions, post-vaccination complications.

Recalled product: BIOFLEKS 0.9% Isotonic Sodium Chloride Sterile, Natrii chloridum, 9 mg/ml, solution for infusion

BIOFLEKS 0.9% Isotonic Sodium Chloride Sterile, Natrii chloridum, 9 mg/ml, solution for infusion

GIF Critical 25.11.2025

Initially, the presence of liquid between the primary container and the outer foil was observed, raising suspicion of a quality defect; however, NIL testing confirmed that the product complies with requirements and poses no risk to patients. Potential effects: no identified health risk.

Recalled product: Xaloptic Combi

Xaloptic Combi

GIF Medium 24.11.2025

Increased solution osmolality and water loss leading to reduced volume may destabilize the tear film and cause ocular discomfort, irritation, burning, subjective visual disturbances, and worsening of dry eye symptoms, especially with long-term use of the product. Potential effects: eye irritation and discomfort, worsening dryness, possible transient visual disturbances.

Recalled product: Fibre 350 g

Fibre 350 g

GIS Critical 20.11.2025

The presence of Salmonella spp. rods was found in one of five samples of the Fibre 350 g dietary supplement from the specified batch, indicating microbiological contamination and a possibility of foodborne infection after consumption. Potential effects: food poisoning, gastrointestinal ailments.

Recalled product: POLIPARIN 25000 IU/5 ml, Heparin sodium, solution for injection and infusion, 25000 IU/5 ml, 5 ml x 1 vial

POLIPARIN 25000 IU/5 ml, Heparin sodium, solution for injection and infusion, 25000 IU/5 ml, 5 ml x 1 vial

GIF Critical 19.11.2025

Reported non‑conformities included “ganglionic thrombosis after administration of the product in several patients”. SMZ analysis confirmed public health hazards and the serious nature of adverse reactions, posing a real risk to patients. Potential effects: thrombosis, vascular complications, risk to health and life.

Recalled product: Vendal retard

Vendal retard

GIF High 07.11.2025

The level of some related substances (a single unknown impurity and morphinone) exceeded the acceptable limit, which may affect the effectiveness and safety of the medicine and pose a real risk to human health. Potential effects: altered drug effect, adverse reactions, health risk.

Recalled product: Storvas CRT

Storvas CRT

GIF High 07.11.2025

It was found that the product does not meet quality requirements: result below the lower specification limit for the dissolution parameter, creating a real risk to patients’ health due to possible lack of efficacy. Potential effects: lack of treatment effectiveness, disease progression, cardiovascular complications.

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.