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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

Syntarpen – recalled product

Syntarpen

CRITICAL 16.01.2026

A risk of microbiological contamination has been identified in batch 2031025 of this parenteral product (powder for solution for injection), which may lead to increased risk to patient health and inadequate medicinal product quality. Potential effects: infections, sepsis, serious complications, lack of treatment efficacy.

Locametz – recalled product

Locametz

MEDIUM 16.01.2026

A single unknown impurity exceeding the quality specification limit was found in batch PG21PL2505, which may affect the medicinal product's quality and does not allow exclusion of a risk to human health. Potential effects: possible unexpected adverse reactions or lack of full certainty regarding treatment safety.

Egoropal – recalled product

Egoropal

CRITICAL 08.01.2026

Serious deficiencies were detected in aseptic manufacturing, creating a threat to product quality. A risk to patients' health or life cannot be excluded, particularly due to the parenteral injectable form of the medicine. Potential effects: infection, severe injection-related complications, lack of therapeutic efficacy.

Egoropal – recalled product

Egoropal

CRITICAL 08.01.2026

A routine FDA inspection revealed serious deficiencies in aseptic manufacturing processes. For a prolonged-release suspension for injection, non-compliance at the sterile manufacturing stage may translate into increased risk to patients' health; a risk to life cannot be excluded. Potential effects: infection, poisoning, severe systemic complications, lack of therapeutic efficacy.

Carmustine Accord – recalled product

Carmustine Accord

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.

Egoropal – recalled product

Egoropal

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.

Egoropal – recalled product

Egoropal

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.

Palifren Long – recalled product

Palifren Long

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.

Palifren Long – recalled product

Palifren Long

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.

Palifren Long – recalled product

Palifren Long

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.

Palifren Long – recalled product

Palifren Long

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.

Clarithromycin Adamed – recalled product

Clarithromycin Adamed

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.

Clarithromycin hameln – recalled product

Clarithromycin hameln

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.

Lorafen – recalled product

Lorafen

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.

Itami – recalled product

Itami

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.

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.

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.