MHRA Issues Class 2 Recall for Mislabelled Boots Paracetamol

On March 4, 2025, the UK MHRA issued a Class 2 recall for Boots Paracetamol 500 mg Tablets (16s) due to a labelling error. The foil blister incorrectly states “Aspirin 300 mg Dispersible Tablets”, though the tablets inside are confirmed to be paracetamol.

While not life-threatening, this mislabelling may lead to confusion or incorrect use, especially for individuals who must avoid aspirin.

Action Required:

• Retailers/Wholesalers: Quarantine and return affected stock within 48 hours.
• Patients: Stop use and return the product to Boots for a full refund.

This recall highlights failures in quality control and the importance of Good Distribution Practice (GDP). Strong recall procedures and clear communication in the supply chain are vital to protect patients.

For more details and images of the affected batch, visit the MHRA website.

20-04-2025