MHRA Issues Class 2 Recall for Batch of Accord Lercanidipine 10mg Tablets

Source published 29 October 2026 by MHRA Safety Alerts

MHRA Issues Class 2 Recall for Batch of Accord Lercanidipine 10mg Tablets

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall concerning a specific batch of lercanidipine hydrochloride 10mg film-coated tablets distributed by Accord-UK Ltd. According to the regulatory notification published on 29 October 2026, the recall has been initiated following a confirmed packaging mix-up in which a blister strip containing a higher strength of the medicine was found inside a 10mg carton.

The alert applies to healthcare professionals across primary and secondary care, including community pharmacists, hospital pharmacy teams, and dispensing general practices. The recall is being conducted at the pharmacy and wholesaler level, meaning that stock must be quarantined and returned through standard distribution channels rather than through a general patient-level recall.

Key Takeaways

• Product affected: Accord-UK Ltd Lercanidipine Hydrochloride 10mg Film-Coated Tablets, 28-tablet pack, Batch No. M2510877 (Expiry 11/2028).
• Reason for recall: A single complaint identified a sealed carton containing one 14-tablet blister strip of 10mg tablets and one 14-tablet blister strip of 20mg tablets (Batch No. M2510831).
• Recall level: Class 2 action restricted to pharmacy and wholesaler level; no blanket patient recall has been ordered.
• Clinical considerations: Lercanidipine 20mg remains within the routine authorised therapeutic dose range; however, inadvertent administration may precipitate exaggerated hypotensive symptoms.
• Immediate action: Healthcare professionals must immediately stop supplying the affected batch, quarantine all remaining inventory, and return it to suppliers.

Affected Batch Details

The details of the specific product and batch affected by the MHRA Class 2 medicines recall are outlined below:

Nature of the Packaging Defect

Accord-UK Ltd initiated the recall after receiving a single customer complaint. Upon examination, a sealed 28-tablet carton of Lercanidipine Hydrochloride 10mg Tablets (Batch No. M2510877) was found to contain:

• One correct blister strip of 14 Lercanidipine Hydrochloride 10mg Tablets (Batch No. M2510877).
• One incorrect blister strip of 14 Lercanidipine Hydrochloride 20mg Tablets (Batch No. M2510831).

The marketing authorisation holder has indicated that the overall probability of this packaging error recurring across the wider batch is very low. In addition, the 10mg and 20mg formulations possess distinct visual differences in tablet colour, reducing the likelihood that a patient would take the wrong tablet without noticing a difference in appearance.

Clinical Risk Assessment

Lercanidipine is a dihydropyridine calcium channel blocker used in the management of essential hypertension. The MHRA and Accord-UK Ltd evaluated the clinical risk associated with this packaging fault and determined that the overall threat to patient safety is low, which justifies conducting the recall at the wholesale and pharmacy level rather than contacting every patient directly.

The clinical assessment noted that a dose of 20mg daily remains within the established, authorised therapeutic dose range for routine use of lercanidipine. Consequently, if a patient prescribed 10mg daily were inadvertently to ingest 20mg daily over a two-week period, the primary clinical expectation is an exaggerated pharmacological response.

Potential adverse effects arising from this increased dosage primarily involve vasodilation and reduction in blood pressure. Clinical features may include:

• Symptomatic hypotension
• Dizziness or light-headedness
• Headache
• Peripheral flushing
• Palpitations or tachycardia

Action Required for Healthcare Professionals

Pharmacy teams, dispensing general practitioners, and pharmaceutical wholesalers must take the following steps immediately:

1. Cease dispensing: Immediately stop supplying Lercanidipine Hydrochloride 10mg Film-Coated Tablets from batch M2510877.
2. Quarantine inventory: Identify, segregate, and quarantine all existing stock from this batch within dispensaries and storerooms.
3. Facilitate returns: Arrange the return of quarantined packs to original wholesalers or suppliers via their established product returns mechanisms.
4. Manage patient enquiries: While a general recall to the patient level has not been instructed, patients may identify an issue independently. If an individual presents a pack containing mixed strengths, pharmacy staff should exercise professional judgement to verify the issue and supply the correct medication promptly.

Advice for Patients and Carers

Healthcare professionals handling enquiries from patients who have been dispensed Accord lercanidipine 10mg tablets should advise them as follows:

• Check the outer carton for batch number M2510877. If this batch is present, inspect the labelling on each individual blister strip inside.
• If all blister strips inside the box are clearly marked as 10mg tablets, patients do not need to take further action and can continue their prescribed treatment.
• If an enclosed blister strip is labelled as 20mg tablets, the patient should not consume those tablets and should return the pack to their dispensing pharmacy for an appropriate replacement.
• Any patient who suspects they have taken a 20mg tablet instead of a 10mg tablet and is experiencing symptoms such as marked dizziness, headache, flushing, or palpitations should seek prompt medical advice.
• Patients should bring their medicine packaging, including the patient information leaflet and any remaining tablets, when attending their GP practice or pharmacy.

Healthcare professionals and patients are reminded to report any suspected adverse drug reactions associated with this product through the MHRA Yellow Card scheme.

Contact Information

Healthcare teams requiring further information regarding the recall may use the following points of contact:

• Medical Information Enquiries: Accord-UK Medical Information Department via email at medinfo@accord-healthcare.com or by telephone on 01271 385257.
• Stock and Returns Enquiries: Accord-UK Customer Services Team via email at customerservices@accord-healthcare.com or by telephone on 0800 373573.
• Defective Medicines Report Centre (DMRC): MHRA, 10 South Colonnade, Canary Wharf, London, E14 4PU; telephone 020 3080 6574; email DMRC@mhra.gov.uk.

Source: MHRA Safety Alerts