MHRA Class 2 recall of lercanidipine 10mg shows how one mixed-strength strip can trigger action

What happened

On 29 October 2026 the MHRA issued Class 2 medicines recall EL(26)A/45 for one batch of Accord UK's lercanidipine hydrochloride 10mg film-coated tablets. The trigger was a single complaint: a 20mg strip was found inside a sealed carton of the 10mg product. The recall targets stock held by pharmacies and wholesalers.

The published summary does not give the batch number, the root cause, the manufacturing or packaging site, or whether any other batches are affected. It also does not say whether any patient was harmed or took the wrong strength. None of that can be assumed. Teams holding Accord lercanidipine should read the full MHRA notice for the batch details and required actions.

Why one complaint is enough

Mixed strengths in a sealed pack are a classic packaging-line failure. A tablet, strip or blister of the wrong strength ends up in a carton labelled for another. The risk is that a patient or pharmacist has no obvious reason to doubt the carton, so the error can pass through the supply chain unnoticed.

That is why a single report can justify a batch-level recall. A complaint cannot show how many other cartons are affected, and a sealed pack that looks normal gives no visible warning. Regulators generally classify recalls by the seriousness of the potential risk. Class 2 sits below the most urgent tier but still requires prompt action on the stock concerned. The MHRA's choice of Class 2 here, with a pharmacy and wholesaler target, reflects its assessment of the information available. The summary does not state its detailed reasoning.

For manufacturers and marketing authorisation holders (MAHs), the practical questions are the usual ones for a mix-up. How well do line clearance and packaging reconciliation work? Can the affected batch be bounded? How quickly can a complaint be turned into a batch decision? The record does not say which of these controls, if any, failed in this case.

A busy day for batch-level actions

The lead record was not the only quality-driven withdrawal on 29 October. Three European regulators reported actions on aflibercept pre-filled syringes for intravitreal injection, all tied to a detachable finger-flange defect.

France's ANSM withdrew one batch each of Biogaran's Afiveg and Advanz Pharma's Mynzepli. It said the flaw could cause needle movement or an incomplete intravitreal dose. Austria's BASG reported a pharmacy-level recall of one Mynzepli 40 mg/ml batch after the MAH identified faulty grip aids. The Czech regulator SÚKL ordered distributors and healthcare facilities to withdraw a specified batch of the product, which its notice spells Mynezpli. Patients need not return packs.

The comparison with the UK case is useful. The lercanidipine problem is a content and labelling mismatch found through a complaint. The aflibercept problem is a device-component defect affecting handling and dosing, and the Austrian record says the MAH identified it. The recall levels also differ: pharmacy and wholesaler stock in the UK and Austria, down to healthcare-facility level in the Czech Republic. For anyone running multi-market recalls, that variation is a reminder that one defect can mean different scopes and instructions in different countries.

Notices that say little

Several records from the same day show how thin public information can be. Greece's EOF announced the recall of Pedmarqsi 80 mg/ml solution for infusion, batches 467504, 477651 and 484536, but the available notice gives no reason or recall level.

BfArM, Germany's regulator, also listed three field safety notices: FIM Medical's Audiolyser ADL Connect, Baxter Medical Systems' TruSystem 7000 and 7500, and Sebia's HYDRAGEL 7 ISO-PAL and HYDRAGEL 15 ISO-PAL. For the Audiolyser and HYDRAGEL listings, the public entry gives no detail on the problem. For the TruSystem notice, the hazard and required actions appear only in the manufacturer's attached advisory.

These are mostly device and diagnostic notices rather than medicines recalls, so they do not bear directly on the lercanidipine case. They do show that regulator listings often point to the manufacturer's own advisory instead of explaining the issue. Quality teams should not treat a bare listing as a complete description of the hazard.

What to watch

For the lercanidipine recall, watch for any update that names a root cause or widens the scope beyond the one batch. Watch also for whether other regulators or markets report related actions. None is mentioned in the records.

For aflibercept, the open questions are whether more batches or products are added and whether recall levels are aligned across markets. For Pedmarqsi, the reason for the recall is not yet known, so any inference would be speculation until EOF or the MAH says more.