Azithromycin 250 mg Capsules
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 4 defect notification · DMRC-34866680
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Azithromycin 250 mg Capsules | PL 19156/0138 | azithromycin dihydrate |
Batches (expiry): ZQ122005A (09/2025), ZQ122006A (09/2025), ZQ122007A (09/2025), ZQ122008A (09/2025), ZQ123003B (09/2026), ZQ123004A (09/2026), ZQ124001A (12/2026), ZQ124002A (12/2026), ZQ124003A (12/2026), ZQ124005A (07/2027), ZQ124006A (07/2027)
Background: Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table above include an outdated PIL. These packs contain a PIL which was approved prior to 2021 but should contain a PIL that was updated in October 2021. Subsequently, a new PIL has been approved in February 2025. The out of date PIL in the tabled batches is missing important updated safety information, please refer to the table in Appendix 2 and a copy of the full PIL is also available on the MHRA website. Advice for Healthcare Professionals: