Medicines recall

Clarithromycin 500 mg powder for concentrate for solution for infusion

Issued on 11 Dec 2025 · source: MHRA — Medicines and Healthcare products Regulatory Agency

Affected batches: 23J097 (30/09/2027), 23J098 (30/09/2027), 23J099 (30/09/2027), 23J100 (30/09/2027), 24A227 (30/11/2027), 24A230 (31/12/2027), 24E038 (31/01/2028), 24E039 (29/02/2028), 24E040 (29/02/2028), 24G130 (30/04/2028), 24G330 (30/04/2028), 24G331 (30/04/2028), 24G333 (30/06/2028), 24I243 (31/07/2028), 24I245 (31/07/2028), 24I400 (31/07/2028), 24I402 (30/09/2028), 24I403 (30/09/2028), 24I404 (30/09/2028), 24I418 (30/09/2028), 24K161 (31/10/2028), 24K162 (31/10/2028), 24K163 (31/10/2028), 24K164 (30/11/2028), 24K165 (30/11/2028), 24K166 (30/11/2028), 24K167 (30/11/2028), 24K168 (30/09/2028), 25D674 (31/03/2029), 25D675 (31/03/2029), 25F174 (31/05/2030), 25F175 (31/05/2030), 25F263 (31/05/2030)

Check the batch number on the pack. The medicine remains licensed; other batches are not affected.

Class 2 recall · DMRC-37790612 · PL: 01502/0135 · licence holder: Hameln Pharma ltd · active ingredient: clarithromycin lactobionate · licence PL: 01502/0135

MHRA alert on GOV.UK ↗ All events: Clarithromycin 500 mg powder for concentrate for solution for infusion

What this means

The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.

Class 2 recall · DMRC-37790612

Product	Licence	Active ingredient	GTIN
Clarithromycin 500 mg powder for concentrate for solution for infusion	PL: 01502/0135	clarithromycin lactobionate	05016386000218

Batches (expiry): 23J097 (30/09/2027), 23J098 (30/09/2027), 23J099 (30/09/2027), 23J100 (30/09/2027), 24A227 (30/11/2027), 24A230 (31/12/2027), 24E038 (31/01/2028), 24E039 (29/02/2028), 24E040 (29/02/2028), 24G130 (30/04/2028), 24G330 (30/04/2028), 24G331 (30/04/2028), 24G333 (30/06/2028), 24I243 (31/07/2028), 24I245 (31/07/2028), 24I400 (31/07/2028), 24I402 (30/09/2028), 24I403 (30/09/2028), 24I404 (30/09/2028), 24I418 (30/09/2028), 24K161 (31/10/2028), 24K162 (31/10/2028), 24K163 (31/10/2028), 24K164 (30/11/2028), 24K165 (30/11/2028), 24K166 (30/11/2028), 24K167 (30/11/2028), 24K168 (30/09/2028), 25D674 (31/03/2029), 25D675 (31/03/2029), 25F174 (31/05/2030), 25F175 (31/05/2030), 25F263 (31/05/2030)

Background: Hameln Pharma Ltd is recalling the batches of Clarithromycin 500 mg powder for concentrate for solution for infusion listed in the table. Following an inspection of the clarithromycin lactobionate raw material manufacturer, the certification of suitability for use in medicines was withdrawn due to non-compliance with Good Manufacturing Practice. The affected batches of Clarithromycin 500 mg powder for concentrate for solution for infusion are listed in the table above. Advice for Healthcare Professionals:

Tracked from information published by the MHRA and the NHSBSA. This information is for guidance only and does not replace advice from your doctor or pharmacist.