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Medicine recalls and shortages › Recalls and defects › 7 Jul 2025
Medicines recall

Zaditen 0.25 mg/ml, eye drops, solution

Issued on 7 Jul 2025 · source: MHRA — Medicines and Healthcare products Regulatory Agency
Affected batches: 4V64 (30/09/2026), 5mL (27/01/2025)
Check the batch number on the pack. The medicine remains licensed; other batches are not affected.
Class 2 recall · DMRC-35933479 · PL: 20162/0019 · licence holder: Laboratoires Théa · active ingredient: ketotifen fumarate · licence PL: 20162/0019
MHRA alert on GOV.UK ↗ All events: Zaditen 0.25 mg/ml, eye drops, solution

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-35933479

ProductLicenceActive ingredientGTIN
Zaditen 0.25 mg/ml, eye drops, solutionPL: 20162/0019ketotifen fumarate3662042000874

Batches (expiry): 4V64 (30/09/2026), 5mL (27/01/2025)

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.