Diabetes Medicine Recall

The Spanish Ministry of Health has issued an alert regarding a well-known diabetes medication.

The Spanish Agency for Medicines and Health Products (AEMPS) has published a health alert concerning one of the most commonly used medications for treating diabetes, specifically type 2 diabetes. This medication is sitagliptin/metformin Normon, prescribed to help lower blood sugar levels in patients with type 2 diabetes.

The AEMPS, which reports to the Ministry of Health, explains in its alert that the identified problem is the presence of impurities exceeding the established limit, which constitutes a quality defect. Although this situation does not pose a life-threatening risk to patients, it does require the precautionary withdrawal of all affected units to guarantee the safety and quality of the medication.

Following this, the Spanish Agency for Medicines and Health Products (AEMPS) has activated the recall procedure and has advised the public to return all distributed units of the affected batches.

Affected batches and expiration dates

Batch: A25A1, expiration date 28/02/2027Batch: A25C1, expiration date 28/02/2027Batch: A2581, expiration date 28/02/2027Batch: A2591, expiration date 28/02/2027Batch: A27X1, expiration date 28/02/2027Batch: A2801, expiration date 28/02/2027Batch: A6MK2, expiration date 30/06/2027Batch: A6ML1, expiration date 30/06/2027Batch: A6MM1, expiration date June 30, 2027Batch: A6MN1, Expiration Date: June 30, 2027Batch: XCKU1, Expiration Date: November 30, 2026Batch: XCKV1, Expiration Date: November 30, 2026Batch: XCKX1, Expiration Date: November 30, 2026Batch: X0RA1, Expiration Date: January 31, 2026Batch: X0R91, Expiration Date: January 31, 2026Batch: X1HX1, Expiration Date: February 28, 2026Batch: X5UF1, Expiration Date: May 31, 2026Batch: X60J1, Expiration Date May 31, 2026Batch: X61X1, Expiration Date: May 31, 2026Batch: X86M1, Expiration Date: July 31, 2026Batch: X86N1, Expiration Date: July 31, 2026Batch: X86P1, Expiration Date: July 31, 2026Batch: X86R1, Expiration Date: July 31, 2026

Pharmacies must immediately withdraw the affected batches, cease dispensing them, and return them to the laboratory through the usual channels. Patients who have a package included in this alert at home should go to their pharmacy for the appropriate procedure.

(News: Spain – Photo: Scott Olson)

Keywords: Diabetes Type 2, Normon, sitagliptin/metformin, Impurities, Withdrawn Batch Numbers

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