MHRA Class 2 Medicines recall: Paracetamol 500 mg tablets (16s) (Boots)

Drug alert number: EL (25)A/10

Date issued: 4 March 2025

Aspar Pharmaceuticals Limited have informed the MHRA of an error related to a batch of Boots Paracetamol 500 mg tablets (16s). The foil blister inside the carton incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. The tablets are confirmed to be Paracetamol 500 mg tablets.

Boots Paracetamol 500 mg tablets (16s) PL 08977/0001

Active Pharmaceutical Ingredient:  paracetamol

Background

Aspar Pharmaceuticals Limited have informed the MHRA of an error related to Boots Paracetamol 500 mg tablets (16s), a product manufactured by Aspar Pharmaceuticals Limited and 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 (16s), incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. Aspar pharmaceuticals have retrieved and inspected the reported batch and confirmed that the tablets in the blister packs are Paracetamol 500 mg tablets. This batch was first distributed on 14/01/2025 and any customers or patients who have purchased the product should return the packs to Boots stores for a full refund, with or without a receipt.

The impacted batch is only sold in Boots stores and Boots online pharmacy and does not impact any other products or batches that share the same PL number packaged in different liveries. If you have any concerns, please contact Aspar Pharmaceuticals Limited using the details below.

Advice for healthcare professionals

Stop supplying the impacted batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Advise patients who have been supplied the impacted batch to stop using the product immediately and return this to Boots Stores, where appropriate. See the Appendix detailing the Boots recall notification in the attachment.

Full drug alert can be viewed here.

Advice for patients

Stop using the impacted batch immediately and return this to Boots stores where a full refund will be provided, with or without a receipt.

Aspar Pharmaceuticals Limited and The Boots Company PLC have confirmed that the tablets in the blister packs are Paracetamol 500 mg tablets and not Aspirin 300 mg Dispersible Tablets.

If you have taken tablets from the impacted batch and have any additional concerns, please seek advice from your pharmacist or other relevant healthcare professional.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For stock control enquiries please contact Aspar Pharmaceuticals Limited Info@aspar.co.uk or telephone 02082059846.

For any additional enquiries to Aspar Pharmaceuticals Limited please email Uma.cherukuri@aspar.co.uk

For Boots customer care enquiries, please telephone 0800 915 0004