Precautionary recall announced for specific batch of Zaditen eye drops in the UK

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A class 2 medicines recall of Zaditen 0.25 mg/ml, eye drops, solution, has been issued in the United Kingdom after Laboratoires Théa notified the Medicines and Healthcare Products Regulatory Agency (MHRA) of an event during manufacturing that may increase the risk of microbial contamination in the product.¹ This recall is precautionary, and there are currently no adverse events reported.

Batch number 4V64 of Zaditen 0.25 mg/ml eye drops solution was first distributed January 27, 2025, and has an expiration date of September 30, 2026.

Due to the recall, healthcare professionals are advised by the MHRA to stop supplying the batch immediately and to quarantine all stock and return it to the supplier it was received from. A confirmed 11,360 packs of the affected batch have been distributed, according to Thea Pharmaceuticals. At the time of this article, there are no reported adverse events or product quality complaints received.

For patients, the MHRA said no further action is required, “as this is a pharmacy- and wholesaler-level recall related to a specific batch of Zaditen 0.25 mg/ml eye drop solution,” according to a press release. Should any suspected adverse reactions arise, they can be reported via the MHRA Yellow Card scheme.¹

For stock control inquiries:¹

• For pharmacies supplied by a wholesaler, returns should be made via the wholesaler.
• For wholesalers, contact Mawdsleys PreWholesaler (MPS) customer services via email: customer.services@mpwpharma.co.uk.
• For healthcare establishments, arrange local destruction and make a claim through MPS via email: customer.services@mpwpharma.co.uk.

For more information email thea-pharma@medinformation.co.uk.

Reference:

1. Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34. GOV.UK. Published July 7, 2025. Accessed July 8, 2025. https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-zaditen-0-dot-25-mg-slash-ml-eye-drops-solution-laboratoires-thea-el-25-a-slash-34