RecallClass 2 · Action within 48 hours

Class 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53

Issued 11 Dec 2025 · EL(25)A/53 · Hameln Pharma ltd

Read and act on the official notice on GOV.UK

Class 2 recall — Action within 48 hours. The MHRA uses Class 2 when: The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
What all four recall classes mean
ClassActionThe MHRA's definition
Class 1Immediate actionThe defect presents a risk of death or disability.
Class 2 this recallAction within 48 hoursThe defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
Class 3Action within 5 daysThe defect is unlikely to cause harm to the patient.
Class 4Caution in useUsually minor defects in packaging or other printed materials.

A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.

The MHRA's summary

Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.

Affected batches

As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.

Batch numberExpiryPack sizeFirst distributed
Clarithromycin 500 mg powder for concentrate for solution for infusion
23J09730/09/20271007/11/2023
23J09830/09/20271011/12/2023
23J09930/09/20271008/01/2024
23J10030/09/20271009/02/2024
24A22730/11/20271010/05/2024
24A23031/12/20271012/08/2024
24E03831/01/20281022/08/2024
24E03929/02/20281017/09/2024
24E04029/02/20281003/10/2024
24G13030/04/20281011/11/2024
24G33030/04/20281028/11/2024
24G33130/04/20281003/12/2024
24G33330/06/20281030/12/2024
24I24331/07/20281007/01/2025
24I24531/07/20281020/01/2025
24I40031/07/20281003/02/2025
24I40230/09/20281012/02/2025
24I40330/09/20281004/03/2025
24I40430/09/20281025/03/2025
24I41830/09/20281014/04/2025
24K16131/10/20281028/04/2025
24K16231/10/20281016/05/2025
24K16331/10/20281027/05/2025
24K16430/11/20281027/05/2025
24K16530/11/20281016/06/2025
24K16630/11/20281008/07/2025
24K16730/11/20281004/08/2025
24K16830/09/20281024/04/2025
25D67431/03/20291026/08/2025
25D67531/03/20291019/09/2025
25F17431/05/20301009/10/2025
25F17531/05/20301031/10/2025
25F26331/05/20301019/11/2025

MHRA's audience tags: Dispensing GP practices, Pharmacy

Pharmshark is not an official alerting route. Make sure your pharmacy receives alerts directly from the MHRA and through your organisation, and always act on the official GOV.UK notice.

Source: the MHRA on GOV.UK. Contains public sector information licensed under the Open Government Licence v3.0. Pharmshark is not affiliated with or endorsed by the MHRA.