Medicines defect noticeMHRA
Azithromycin 250 mg Capsules defect notice over a labelling error
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.
Check your product
Only products that match these details are covered. Have your pack in front of you.
29 identifiers listed for this notice.
Product 1 4 Cap/pack
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- ZQ122005A
- ZQ124001A
- ZQ124002A
- ZQ124003A
- ZQ124006A
- Product licenceThe PL number on the carton.
- PL 19156/0138
- ExpiryOn the carton, blister or label.
- 09/2025
- 12/2026
- 07/2027
- First distributedOn the product, its label or its packaging.
- 07/11/2023
- 28/02/2024
- 24/05/2024
- 22/07/2024
- 07/01/2025
Product 2 6 Cap/pack
- Batch code
- ZQ122006A
- ZQ122007A
- ZQ122008A
- ZQ123003B
- ZQ123004A
- ZQ124005A
- Expiry
- 09/2025
- 09/2026
- 07/2027
- First distributed
- 14/02/2023
- 11/08/2023
- 08/11/2023
- 26/01/2024
- 27/02/2024
- 19/12/2024
What to do now
The issue with Azithromycin 250 mg Capsules is information: something on the packaging or leaflet is wrong or missing.
- 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
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/11). Quoted as issued.
Summary
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.
The risk
This recall notification has been updated since its initial publication on 11 March 2025 to include the correct information in relation to the safety updates in the Patient Information Leaflet (PIL) and the changes that have been made in line with reference product PIL.
Advice for healthcare professionals
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product. When products from batches included in the table are supplied or dispensed, please ensure that patients are aware of the missing information which is summarised in the ‘Advice for Patients’ box below and provided in Appendix 2 . As the patients would not find the correct PIL in the packs. Please inform the patients that the latest PIL for Azithromycin Capsules is available on the MHRA website.
Healthcare professionals and patients may notice that information relating to other medicines have been removed from the latest PIL, due to routine periodic updates and new safety information in line with the reference product information. Please contact safety.uk@lambda-cro.com for more information.
Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. This does not affect the quality of the product. There is updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest PIL is available on the MHRA website.
There is some missing information which is presented below:
What you need to know before you take Azithromycin
Other medicines and Azithromycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
hydroxychloroquine or chloroquine (used to treat autoimmune diseases including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart
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
Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. This does not affect the quality of the product. There is updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest PIL is available on the MHRA website.
There is some missing information which is presented below:
What you need to know before you take Azithromycin
Other medicines and Azithromycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
hydroxychloroquine or chloroquine (used to treat autoimmune diseases including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart
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 Azithromycin 250 mg Capsules been recalled?
The issue with Azithromycin 250 mg Capsules is information: something on the packaging or leaflet is wrong or missing. 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?
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?
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?
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.