Egoropal Recall: Affected Batches & Production Issues

A key antipsychotic medication, Egoropal, containing the active ingredient paliperidone, is being withdrawn from circulation across the country. The drug, used in the treatment of schizophrenia and schizoaffective disorders, impacts dopamine and serotonin levels in the brain. Egoropal is administered as a long-acting injectable suspension, providing sustained release of the medication after a single injection.

The medication is primarily indicated for:

• The treatment of schizophrenia, including maintenance therapy to reduce the risk of relapse,

• The treatment of schizoaffective disorders, as determined by a physician.

Egoropal is a prescription medication and must be used under the guidance of a healthcare professional.

The Polish Medicines Agency (GIF) issued a decision on January 8, 2026 (decision number 1/WC/ZW/2026) ordering the recall of specific batches of Egoropal and prohibiting the introduction of those batches into the market. This action impacts the availability of the medication for patients relying on this particular formulation.

The following information details the affected product:

Egoropal (Paliperidonum) 75 mg

• Form: Extended-release injectable suspension in a vial-syringe,

• Packaging: 1 vial-syringe 75 mg + 2 needles,

• GTIN: 05995327188706,

• Marketing Authorization Number: 27352.

Batches subject to recall:

• 4400718 – Expiration Date: 03/2027,

• 4500766 – Expiration Date: 05/2028,

• 4501274 – Expiration Date: 08/2028.

Egoropal (Paliperidonum) 150 mg

• Form: Extended-release injectable suspension in a vial-syringe

• Packaging: 1 vial-syringe 150 mg + 2 needles,

• GTIN: 05995327188720,

• Marketing Authorization Number: 27354.

Batches subject to recall:

• 4400293 – Expiration Date: 01/2027,

• 4400851 – Expiration Date: 06/2026,

• 4500598 – Expiration Date: 04/2028,

• 4500832 – Expiration Date: 05/2028,

• 4500892 – Expiration Date: 05/2028,

• 4501060 – Expiration Date: 06/2028,

• 4501376 – Expiration Date: 08/2028.

• Marketing Authorization Holder: Egis Pharmaceuticals PLC (Budapest, Hungary).

See also: Health authorities advise against consuming this children’s product, also subject to recall

The decision stems from findings during a routine inspection of the manufacturer’s facilities by the U.S. Food and Drug Administration (FDA), which revealed “serious deficiencies in aseptic manufacturing processes.” The recall underscores the importance of stringent quality control in pharmaceutical production.

Documents indicate that a retrospective assessment concluded the “assessed risk to product quality and patient safety (…) is high,” prompting the marketing authorization holder to halt inventories and recommend market actions, including the recall.

The GIF also highlighted the drug’s administration route (parenteral product). The agency emphasized that inconsistencies during manufacturing of this type of medication can pose elevated risks to patients, leading to the decision to remove the product from the supply chain.

Pharmacies and wholesalers are instructed not to distribute the recalled batches, and existing inventories are subject to recall procedures. This recall may temporarily impact the supply of Egoropal for patients requiring this specific medication.

Patients with questions regarding the batch number of their medication should consult with their healthcare provider or pharmacist. The recall applies only to the specific batch numbers and expiration dates identified by the GIF.

The decision was made under the provisions of Polish Pharmaceutical Law. The ruling indicates that no appeal is permitted, although parties may request a reconsideration of the decision within 14 days. The immediate enforcement order signifies that the recall is to be implemented without delay.

Magdalena Pietras, Reporter

Sources

1. Polish Medicines Agency (GIF)