Medicines defect noticeMHRA
Products defect notice over a labelling error
Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
What to do now
A printing or labelling mistake affects some packs of Products.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
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
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/42). Quoted as issued.
Summary
Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
The risk
DMRC reference number DMRC - 35766519 Marketing Authorisation Holder
Advice for healthcare professionals
Healthcare professionals are advised to review the content of this notification, as it provides information that is missing from the current PIL. Whilst this information may already be known, this notification provides a reminder of the safety information, which should be considered when prescribing and dispensing these products.
Healthcare professionals involved in dispensing of these products should, where possible, signpost new patients on these medicines to the missing safety information in the PIL. Upon request, Ipca Laboratories UK Ltd will provide hard copies of the updated PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact quality@ipcauk.com with your details, i.e. address, product with batch details, required number of leaflets.
The product quality is not impacted. Due to the requirement for these products to support the UK market, the MHRA in discussion with the Department of Health and Social Care (DHSC) consider that batches which are currently packed and available for distribution, will continue to be distributed. Details of the specific batches can be obtained by contacting quality@ipcauk.com directly.
Ipca Laboratories UK Ltd have confirmed that all new batches produced by the manufacturing site, will be packed with the corrected PILs only and these batches will be available for distribution to UK market from November 2025 onwards.
Patients should continue to take medicines as prescribed by your healthcare professional. The product quality of the impacted batches is not affected, however there is some missing safety information in the Patient Information Leaflet (PIL) that patients should be aware of. Details of the missing safety information can be found in the Appendices related to each individual product.
Appendix 1 - Allopurinol 100 mg tablets & Allopurinol 300 mg tablets
Appendix 2 - Amlodipine 5 mg Tablets & Amlodipine 10 mg Tablets
Appendix 3- Hydroxychloroquine sulfate 200 mg film-coated tablets
Appendix 4- Levofloxacin 250mg Film Coated Tablets & Levofloxacin 500mg Film Coated Tablets
Appendix 5 - Gabapentin 100mg capsules, Gabapentin 300mg capsules and Gabapentin 400mg capsules
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Advice for patients
Patients should continue to take medicines as prescribed by your healthcare professional. The product quality of the impacted batches is not affected, however there is some missing safety information in the Patient Information Leaflet (PIL) that patients should be aware of. Details of the missing safety information can be found in the Appendices related to each individual product.
Appendix 1 - Allopurinol 100 mg tablets & Allopurinol 300 mg tablets
Appendix 2 - Amlodipine 5 mg Tablets & Amlodipine 10 mg Tablets
Appendix 3- Hydroxychloroquine sulfate 200 mg film-coated tablets
Appendix 4- Levofloxacin 250mg Film Coated Tablets & Levofloxacin 500mg Film Coated Tablets
Appendix 5 - Gabapentin 100mg capsules, Gabapentin 300mg capsules and Gabapentin 400mg capsules
Patients who experience adverse reactions or have any questions about their 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 Products been recalled?
A printing or labelling mistake affects some packs of Products. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.