MHRA recalls blood pressure tablets batch over packaging error
MHRA recalls blood pressure tablets over packaging error

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent warning over a packaging error affecting one batch of blood pressure tablets, prompting an immediate recall and advice for patients to check their blister strips.

The recall concerns Lercanidipine Hydrochloride 10mg Film-Coated Tablets, a prescription-only medicine used to reduce blood pressure. Accord, the manufacturer, reported that a carton of Accord-UK Ltd Lercanidipine Hydrochloride 10mg Tablets was found to contain a blister strip of Lercanidipine Hydrochloride 20mg Tablets.

Patients urged to check blister strips

The MHRA is advising patients to carefully inspect the blister strips inside their packs. If the carton contains strips labelled as Lercanidipine Hydrochloride 10mg Tablets, they can continue taking the medicine. However, if a strip is labelled as 20mg, patients should not take the medicine and should contact their pharmacy.

The affected batch number is M2510877, with an expiry date of 11/2028 and a pack size of 28. The product was first distributed on 24/6/26. The complainant reported that a sealed carton contained one blister strip of the correct tablets and one strip of Lercanidipine Hydrochloride 20mg Tablets (Batch No. M2510831).

Side-effects warning and guidance

The MHRA is advising those experiencing specific side-effects, who believe they may have taken the incorrect dosage, to seek immediate medical advice. Side-effects listed include dizziness, headaches, flushing or palpitations.

If someone prescribed 10mg inadvertently took 20mg daily for approximately two weeks, the anticipated risk would be that the effect of the drug would be excessively strong, potentially leading to a reduction in blood pressure along with symptoms such as dizziness, headache, flushing, palpitations or symptomatic hypotension.

However, the MHRA states that 20mg remains within the authorised therapeutic dose range for routine use of this product, and the tablets have distinct colours. The occurrence of the defect is believed to be "very low".

Recall at pharmacy and wholesaler level

Healthcare professionals have been instructed to "stop supplying the above batch immediately" and to quarantine all remaining stock and return it to their supplier using the approved process. The recall is at the pharmacy and wholesaler level and not directed to patient level, as 20mg remains within the authorised therapeutic dose range.

Should a patient present a pack with the incorrect medicine, pharmacy teams should exercise their professional judgement to supply the correct medication. For medical information enquiries, contact Accord-UK Medical Information Department at medinfo@accord-healthcare.com or telephone 01271 385257. For stock control enquiries, contact Accord-UK Customer Services Team at customerservices@accord-healthcare.com or telephone 0800 373573.