MHRA Class 2 Recall due to Blister Pack Mislabeling

On 4 March 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a Class 2 medicines recall.

What happened?

A Marketing Authorisation Holder (MAH) informed the MHRA of an error related to Boots Paracetamol 500 mg tablets (16s). The product, manufactured by Aspar Pharmaceuticals Limited, was distributed by The Boots Company PLC.

Following a customer complaint, it was identified that the foil blister inside the carton of Paracetamol 500 mg tablets incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. While the tablets themselves have been confirmed to be paracetamol and not aspirin, the mislabeling presents a significant risk of medication errors, potentially leading to incorrect medication use and patient confusion.

As required for Class 2 recalls, action must be taken within 48 hours to ensure the affected products are promptly removed from the supply chain.

Types of Recalls

The MHRA classifies drug recalls into different categories based on the risk to health:

• National Patient Safety Alert (equivalent to Class 1 Medicines Recall) – The defect presents a risk of death or disability.
• Class 2 – The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
• Class 3 – The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification.
• Medicines Notification: Caution in use, Class 4 – There is no threat to patients or no serious defect likely to impair product use or efficacy.
• Company-led Medicines Recall/Notification – The licence holder is able to identify the affected customers.

For further details, please refer to the MHRA's explanation table for Medicines Recall and Notification classifications and the associated defect risk classification.

Advice for Retailers, Wholesalers, Healthcare Professionals, and Patients

All parties in the supply chain are required to immediately stop supplying the impacted batch, quarantine all stock, and return it.

All patients who have received the affected product are strongly advised to stop using it immediately and return it to Boots stores, where a full refund will be provided with or without a receipt.

Lessons Learned: Quality Management and GDP Compliance in Drug Recalls

This incident highlights a failure in the pharmaceutical Quality Management System (QMS) and a lapse in oversight by the Qualified Person (QP), as such an error should have been identified before the product entered the market. At the same time, the case underscores the critical role of wholesalers and pharmacies in ensuring patient safety.

In line with Good Distribution Practice (GDP), they must act immediately to quarantine and remove the affected batch from circulation, preventing potential medication errors.

Efficient recall procedures and communication within the supply chain are essential to minimizing risks, demonstrating why GDP compliance and robust control mechanisms at every distribution level are crucial.

The MHRA's full ‘Medicines Recall/Notification’, including all relevant information, photos of the affected batch, and supplementary documents, can be found on the authority's website.