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Medicines recallMHRA

Boots Paracetamol 500 mg tablets (16s) recalled over a packaging defect

Packaging or device defectHigh riskClass 2

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.

Check your product

Only products that match these details are covered. Have your pack in front of you.

4 identifiers listed for this notice.

  • Boots Paracetamol 500 mg tablets (16s) 16

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 241005
    Product licenceThe PL number on the carton.
    • PL 08977/0001
    ExpiryOn the carton, blister or label.
    • 12.2029
    First distributedOn the product, its label or its packaging.
    • 14/01/2025

What to do now

The problem with Boots Paracetamol 500 mg tablets (16s) is the pack or device, such as a syringe, cap, blister or inhaler.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/10). Quoted as issued.

Summary

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.

The risk

DMRC reference number DMRC-34874518 Marketing Authorisation Holder

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.

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.

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.

Open the MHRA notice

Questions

Why has Boots Paracetamol 500 mg tablets (16s) been recalled?

The problem with Boots Paracetamol 500 mg tablets (16s) is the pack or device, such as a syringe, cap, blister or inhaler. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

How do I know if my medicine is affected?

Compare the batch code, product licence, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

Where was Boots Paracetamol 500 mg tablets (16s) sold?

The notice names Boots. Products bought elsewhere are covered too if they match the details listed.

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