oAlert.pl

Recalled Medicines & supplements – Current GIS Alerts 2026

Found 685 recalled products in the Medicines & supplements category. Check batch numbers, shops, and hazard information.

Common hazards in this category

All recalled products

Lorafen – recalled product

Lorafen

CRITICAL 17.12.2025

Stability studies showed failure to meet the minimum limit for the active substance release parameter. Exceeding the acceptance criteria constitutes a real and direct risk to patients' health or life until the cause of the deviation is clarified. Potential effects: lack of treatment efficacy, worsening of the condition, complications requiring medical intervention.

Itami – recalled product

Itami

MEDIUM 12.12.2025

the identified quality defect consists in insufficient adhesion of the patch to the skin. Because of the defect the patch does not remain firmly attached to the skin surface, preventing the product from achieving its intended therapeutic effect. Potential effects: ineffective pain treatment, worsening of symptoms.

PHELINUN – recalled product

PHELINUN

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.

Vitamina C Synteza – recalled product

Vitamina C Synteza

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.

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) – 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)

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.

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

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

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.

Xaloptic Combi – recalled product

Xaloptic Combi

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.

Fibre 350 g – recalled product

Fibre 350 g

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.

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

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

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.

Vendal retard – recalled product

Vendal retard

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.

Storvas CRT – recalled product

Storvas CRT

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.

Euthyrox N 25 – recalled product

Euthyrox N 25

MEDIUM 07.11.2025

The acceptance limit specified in the quality specification for this parameter (maximum active substance content) was exceeded. Therefore, a risk to human health from leaving this batch of the medicinal product on the market cannot be excluded. Potential effects: levothyroxine overdose, hormonal disturbances, adverse reactions.

Nimbex – recalled product

Nimbex

CRITICAL 24.10.2025

A possible presence of glass particles was identified in ampoules of Nimbex solution for intravenous injection, which may cause direct adverse health consequences and pose a risk to patients’ health or life. Potential effects: vascular damage, embolism, inflammation, acute complications, life‑threatening events.

Mivacron – recalled product

Mivacron

CRITICAL 24.10.2025

The presence of glass particles in ampoules of an intravenously administered medicine cannot be excluded, which may cause direct negative health consequences for patients, including vascular damage and embolic events. Potential effects: vessel damage, thromboembolic complications, acute reactions, life‑threatening events.

Benlek – recalled product

Benlek

MEDIUM 17.10.2025

The product does not meet quality requirements due to a failed test of “Chromatographic purity of thiamine hydrochloride: any unspecified impurity”; the impurity was identified as a metamizole derivative. Potential effects: possible unpredictable adverse reactions and reduced treatment efficacy.

Kidofen – recalled product

Kidofen

MEDIUM 13.10.2025

Exceedance of the quality specification limit for the single impurity parameter was found, which may affect the effectiveness and safety of the medicine; a risk to children’s health cannot be excluded. Potential effects: possible adverse reactions, lack of efficacy, complications in children.

Signopam – recalled product

Signopam

MEDIUM 06.10.2025

Reduced temazepam release may lead to insufficient patient exposure, lack of hypnotic and sedative efficacy, and risk of inappropriate treatment, including dose escalation and variability of effect. Potential effects: reduced treatment efficacy, need to change therapy.

Rivaldo – recalled product

Rivaldo

HIGH 02.10.2025

Failure to meet quality requirements consists in exceeding the lower limit for active substance content and exceeding the upper limit for average capsule mass, creating a real risk to patients’ health due to lack of the intended efficacy of the product. Potential effects: lack of treatment efficacy, worsening of patients’ health.

Liv 52 – recalled product

Liv 52

MEDIUM 30.09.2025

There is no clear description of a specific hazard in the provided part of the decision; however, the medicinal product was withdrawn from the market and its placing on the market was prohibited in Poland, indicating significant concerns about its quality or safety. Potential effects: lack of treatment efficacy or adverse reactions.

Cozaar – recalled product

Cozaar

MEDIUM 29.09.2025

Damage to the immediate packaging (blister foil cracking) was found, causing loss of tightness and no guarantee of product quality, which may lead to tablet degradation and exposure to moisture and contaminants. Potential effects: reduced treatment efficacy, adverse effects.

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.