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MHRA Issues Alert over Lercanidipine Label Error, Recall Initiated

Life Sciences and Bio Pharma

Business Honor
18 April, 2025

Labeling error in hypertension drug prompts MHRA alert, patient guidance and precautionary product recall.

A safety alert has been issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) on a labeling error affecting 20 mg tablets of ercanidipine hydrochloride, a calcium channel blocker that is frequently used for hypertension. The product strength is correctly indicated as 20 mg on the blister strip and top of the box; however the problematic batch MD4L07, made by Recordati Pharmaceuticals Limited, with an expiration date of 01/2028, has been mistakenly labeled as 10 mg on several sides of the carton.

Patients who are provided the lower 10 mg dose run a serious risk of inadvertently overdosing due to this mislabeling. Patients are advised to seek advice from their pharmacist or general practitioner, even though the 20 mg tablets are scored and can be safely divided for short-term use. Before administering the tablet, the MHRA recommends checking its strength right away on the package foil.

As a precaution, Recordati has started a product recall. Healthcare providers and pharmacists are directed to stop distributing the impacted batch and are advised to send the remaining inventory back to the supplier.

This incident demonstrates how important it is for pharmaceutical manufacturers to have strong quality guarantee procedures and investigation needed post the marketing. The MHRA still places important value on patient safety and promotes using the Yellow Card Scheme to report side events.

In the life sciences, label accuracy is important, especially for long-term drugs like antihypertensive when precise dosage is required. The recall shows how regulatory agencies uphold public health through prompt pharmacovigilance.