The Chief Pharmaceutical Inspector has withdrawn one batch of the medicinal product Loperamid APTEO MED 2 mg from marketing nationwide.
Popular anti-diarrheal drug recalled. Check the batch number
Published Feb. 10, 2026 07:18
The decision was given immediate enforceability. The reason is the non-fulfillment of quality requirements for the content of the active substance, found during stability testing.
The Chief Pharmaceutical Inspector, in a decision dated February 9, 2026, withdrew the medicinal product Loperamid APTEO MED (Loperamidi hydrochloridum), 2 mg, hard capsules, package of 20 capsules, with batch number IJW024001, with expiration date of 31.12.2026, from the market nationwide.
The entity responsible for the drug is SYNOPTIS PHARMA Sp. z o.o., based in Warsaw. The product was distributed exclusively on the Polish market.
As can be seen from the justification of the decision, the Main Pharmaceutical Inspectorate received a notification from the responsible entity with a recommendation to withdraw the indicated batch of the product. The reason was the result below the lower limit of the quality specification in the parameter "content of the active substance", obtained in the 18th month of stability testing, conducted under storage conditions of 25°C and 60% relative humidity (RH).
Loperamide APTEO MED prolongs the time of passage of food content through the intestines, reduces the excretion of water and electrolytes, and reduces the urgency of defecation. It is used in the symptomatic treatment of acute diarrhea in adults and adolescents aged 12 years and over; in the symptomatic treatment of acute episodes of diarrhea associated with irritable bowel syndrome in adults (18+), after prior medical diagnosis.
Source: GIF
