LekoskopLekoskop
EN All changes
Medicine recalls and shortages › Recalls and defects › 15 Dec 2025
Medicines recall

Prednisolone 5mg Soluble Tablets

Issued on 15 Dec 2025 · source: MHRA — Medicines and Healthcare products Regulatory Agency
Affected batches: 2409006 (31/05/2027), 2409007 (31/05/2027)
Check the batch number on the pack. The medicine remains licensed; other batches are not affected.
Class 3 recall · DMRC-37820855 · PL: 28444/0276 · licence holder: Activase Pharmaceuticals Limited · active ingredient: prednisolone sodium phosphate · licence PL: 28444/0276
MHRA alert on GOV.UK ↗ All events: Prednisolone 5mg Soluble Tablets

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 3 recall · DMRC-37820855

ProductLicenceActive ingredientGTIN
Prednisolone 5mg Soluble TabletsPL: 28444/0276prednisolone sodium phosphate05060014446695

Batches (expiry): 2409006 (31/05/2027), 2409007 (31/05/2027)

Background: Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time. The blister pocket swelling is due to gas (carbon dioxide) build up, from gradual excipient reaction with trace amounts of moisture. The image below shows an impacted blister strip. 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.